Celia Garcia-Malo, Diego Garcia-Borreguero, Michael H Silber
{"title":"Efficacy and safety of intravenous iron in restless legs syndrome patients with normal serum ferritin levels: a stratified sub-analysis.","authors":"Celia Garcia-Malo, Diego Garcia-Borreguero, Michael H Silber","doi":"10.5664/jcsm.11846","DOIUrl":"https://doi.org/10.5664/jcsm.11846","url":null,"abstract":"<p><strong>Study objectives: </strong>Restless legs syndrome (RLS) has long been associated with iron deficiency. Current clinical guidelines recommend intravenous (IV) iron therapy for patients with serum ferritin levels ≤ 100 µg/L, but the effectiveness and safety of IV iron in patients with ferritin levels between 100-300 µg/L have not been well established. The aim of this study is to assess the efficacy and safety of IV iron in RLS patients with serum ferritin levels both below and above the 100 µg/L threshold, hypothesizing no significant differences in therapeutic response between these groups.</p><p><strong>Methods: </strong>We conducted a longitudinal retrospective analysis of 58 RLS patients treated with 1000 mg of ferric carboxymaltose (FCM), with baseline serum ferritin concentrations <300 µg/L. Patients were divided into two groups: Group A (serum ferritin <100 µg/L) and Group B (serum ferritin 100-300 µg/L). We compared changes in symptom severity (IRLS scale), substantia nigra iron deposits (SNEI), and systemic iron parameters.</p><p><strong>Results: </strong>Both groups showed similar improvements in IRLS scores and SNEI. Serum ferritin increased significantly in Group B post-treatment, while no major differences were observed in TSAT or serum transferrin levels between the two groups. Regarding risk of iron overload, only 2 patients (Group B) showed a TSAT >45%. No harm resulted to either patient, with no hepatic dysfunction observed.</p><p><strong>Conclusions: </strong>IV iron therapy is effective in RLS patients without hepatic iron overload with serum ferritin levels ranging from 100-300 µg/L. These findings challenge current guidelines and suggest that IV iron could be considered for a broader range of RLS patients.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144977342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M Safwan Badr, Rami N Khayat, J Shirine Allam, Suzanne Hyer, Reem A Mustafa, Matthew T Naughton, Susheel Patil, Grace Pien, Winfried Randerath, Christine Won
{"title":"Treatment of central sleep apnea in adults: an American Academy of Sleep Medicine clinical practice guideline.","authors":"M Safwan Badr, Rami N Khayat, J Shirine Allam, Suzanne Hyer, Reem A Mustafa, Matthew T Naughton, Susheel Patil, Grace Pien, Winfried Randerath, Christine Won","doi":"10.5664/jcsm.11858","DOIUrl":"10.5664/jcsm.11858","url":null,"abstract":"<p><strong>Introduction: </strong>This guideline establishes clinical practice recommendations for treatment of central sleep apnea (CSA) syndromes in adults.</p><p><strong>Methods: </strong>The American Academy of Sleep Medicine (AASM) commissioned a task force of experts in sleep medicine to develop recommendations and assign strengths based on a systematic review of the literature and an assessment of the evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology. The task force provided a summary of the relevant literature and the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations that support the recommendations. The AASM Board of Directors approved the final recommendations.</p><p><strong>Good practice statement: </strong>The following good practice statement is based on expert consensus, and its implementation is necessary for the appropriate and effective management of patients with CSA. The optimal approach to CSA treatment should incorporate clinical features, co-morbid conditions, and polysomnographic findings in an individualized manner. Specifically, clinicians must prioritize optimizing therapy for the conditions contributing to central apneas and improving patient-reported outcomes rather than solely focusing on eliminating disordered breathing events. Once therapy for CSA has been initiated, persistence of central respiratory events should prompt re-evaluation of the underlying risk factors and consideration of alternative treatment options.</p><p><strong>Recommendations: </strong>The following recommendations are intended as a guide for clinicians in choosing a specific treatment for adults with CSA. Each recommendation statement is assigned a strength (\"Strong\" or \"Conditional\"). A \"Strong\" recommendation (i.e., \"We recommend…\") is one that clinicians should follow under most circumstances. A \"Conditional\" recommendation (i.e., \"We suggest …\") is one that clinicians should offer to most patients if clinically appropriate. Some recommendations include remarks that provide additional context to guide clinicians with the implementation of this recommendation.</p><p><p>1. The AASM suggests using continuous positive airway pressure (CPAP) over no CPAP in adults with CSA due to the following etiologies: primary CSA, CSA due to heart failure, CSA due to medication or substance use, treatment-emergent CSA, and CSA due to a medical condition or disorder. (Conditional recommendation, low certainty.).</p><p><p>2. The AASM suggests using bilevel positive airway pressure (BPAP) <i>with a backup rate</i> over no BPAP with a backup rate in adults with CSA due to the following etiologies: primary CSA, CSA due to medication or substance use, treatment-emergent CSA, and CSA due to a medical condition or disorder. (Conditional recommendation, very low certainty).</p><p><p>3. The AASM suggests against the use of BPAP <i>without a bac","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876559","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
M Safwan Badr, Rami N Khayat, J Shirine Allam, Suzanne Hyer, Reem A Mustafa, Matthew T Naughton, Susheel Patil, Grace Pien, Winfried Randerath, Christine Won
{"title":"Treatment of central sleep apnea in adults: an American Academy of Sleep Medicine systematic review, meta-analysis, and GRADE assessment.","authors":"M Safwan Badr, Rami N Khayat, J Shirine Allam, Suzanne Hyer, Reem A Mustafa, Matthew T Naughton, Susheel Patil, Grace Pien, Winfried Randerath, Christine Won","doi":"10.5664/jcsm.11860","DOIUrl":"10.5664/jcsm.11860","url":null,"abstract":"<p><strong>Introduction: </strong>This systematic review provides supporting evidence for the accompanying clinical practice guideline on the treatment of central sleep apnea (CSA) syndrome in adults.</p><p><strong>Methods: </strong>The American Academy of Sleep Medicine commissioned a task force of experts in sleep medicine. A systematic review was conducted to identify studies that compared the use of positive airway pressure therapies (PAP), non-PAP therapies, and pharmacological treatment to no treatment to improve patient-important outcomes. Statistical analyses were performed to determine the clinical meaningfulness of using various interventions to treat CSA in adults. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process was used to assess the evidence for making recommendations.</p><p><strong>Results: </strong>The literature search resulted in 6,701 articles out of which 103 articles provided data suitable for statistical analyses. The task force provided a detailed summary of the evidence along with the certainty of evidence, the balance of benefits and harms, patient values and preferences, and resource use considerations.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144876560","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The effect of zolpidem on CPAP acclimatization in patients with OSA: a crossover, randomized, double-blinded, placebo-controlled trial.","authors":"Piyakorn Pisalnoradej, Wish Banhiran, Navarat Kasemsuk","doi":"10.5664/jcsm.11850","DOIUrl":"https://doi.org/10.5664/jcsm.11850","url":null,"abstract":"<p><strong>Study objectives: </strong>To evaluate the short-term effect of zolpidem on continuous positive airway pressure (CPAP) acclimatization in patients with obstructive sleep apnea (OSA) compared with placebo.</p><p><strong>Methods: </strong>This randomized, double-blind, placebo-controlled crossover trial enrolled CPAP-naive OSA patients who were indicated for CPAP therapy. Participants were randomly assigned to receive either zolpidem 10 mg or an identical placebo capsule, administered 30 minutes before bedtime for 1 week. In the second week, they crossed over to the alternate treatment. A 24-hour washout period separated the two treatment phases.</p><p><strong>Results: </strong>Twenty-eight participants (mean age 54.5 ± 13.7 years; 57.1% male) completed the study. The mean CPAP usage per night did not differ significantly between zolpidem and placebo (mean difference 0.18, 95% CI -0.39 to 0.75). The percentage of nights with CPAP use ≥ 4 hours also showed no significant difference (mean difference 2.60, 95% CI -5.65 to 10.87). Treatment sequence did not affect CPAP adherence (<i>P</i> = 0.87). Subgroup analyses by sex, disease severity, and arousal index revealed no significant impact of zolpidem on adherence. No serious adverse events were reported, and the most common minor adverse event was dizziness (7.14%).</p><p><strong>Conclusions: </strong>Short-term zolpidem use did not improve CPAP adherence during the acclimatization period. These findings underscore the importance of employing multiple acclimatization strategies rather than relying on routine zolpidem use. Larger-scale studies with extended follow-up are warranted to confirm these results.</p><p><strong>Clinical trial registration: </strong>Registry: ClinicalTrials.gov; Identifier: NCT06084130.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144823125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ayush Tripathi, Samaneh Nasiri, Wolfgang Ganglberger, Thijs Nassi, Erik-Jan Meulenbrugge, Haoqi Sun, Katie L Stone, Emmanuel Mignot, Dennis Hwang, Lynn Marie Trotti, Matthew A Reyna, Gari D Clifford, Umakanth Katwa, Robert J Thomas, M Brandon Westover
{"title":"Automated analysis of the AASM Inter-Scorer Reliability gold standard polysomnogram dataset.","authors":"Ayush Tripathi, Samaneh Nasiri, Wolfgang Ganglberger, Thijs Nassi, Erik-Jan Meulenbrugge, Haoqi Sun, Katie L Stone, Emmanuel Mignot, Dennis Hwang, Lynn Marie Trotti, Matthew A Reyna, Gari D Clifford, Umakanth Katwa, Robert J Thomas, M Brandon Westover","doi":"10.5664/jcsm.11848","DOIUrl":"10.5664/jcsm.11848","url":null,"abstract":"<p><strong>Study objectives: </strong>To compare the performance of a comprehensive automated polysomnogram (PSG) analysis algorithm-CAISR (Complete Artificial Intelligence Sleep Report)-to a multi-expert gold standard panel, crowdsourced scorers, and experienced technicians for sleep staging and detecting arousals, respiratory events, and limb movements.</p><p><strong>Methods: </strong>A benchmark dataset of 57 PSG records (Inter-Scorer Reliability dataset) with 200 30-second epochs scored per AASM guidelines was used. Annotations were obtained from (1) the AASM multi-expert gold standard panel, (2) AASM Inter-Scorer Reliability (ISR) platform users (\"crowd,\" averaging 6,818 raters per epoch), (3) three experienced technicians, and (4) CAISR. Agreement was assessed via Cohen's Kappa (κ) and percent agreement.</p><p><strong>Results: </strong>Across tasks, CAISR achieved performance comparable to experienced technicians but did not match consensus-level agreement between the multi-expert gold standard and the crowd. For sleep staging, CAISR's agreement with multi-expert gold standard was 82.1% (κ = 0.70), comparable to experienced technicians but below the crowd (κ = 0.88). Arousal detection showed 87.81% agreement (κ = 0.45), respiratory event detection 83.18% (κ = 0.34), and limb movement detection 94.89% (κ = 0.11), each aligning with performance equivalent to experienced technicians but trailing crowd agreement (κ = 0.83, 0.78 and 0.86 for detection of arousal, respiratory events and limb movements respectively).</p><p><strong>Conclusions: </strong>CAISR achieves experienced technician-level accuracy for PSG scoring tasks but does not surpass the consensus-level agreement of a multi-expert gold standard or the crowd. These findings highlight the potential of automated scoring to match experienced technician-level performance while emphasizing the value of multi-rater consensus.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144823124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Symptomatic opioid users are more likely to have greater improvements in sleepiness and quality of life with adaptive servo-ventilation treatment.","authors":"Jean-Louis Pepin, Adam V Benjafield, Michael Arzt","doi":"10.5664/jcsm.11836","DOIUrl":"https://doi.org/10.5664/jcsm.11836","url":null,"abstract":"","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":""},"PeriodicalIF":2.9,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144776710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Slobodanka Pejovic, Alexandros N Vgontzas, Julio Fernandez-Mendoza, Fan He, Yun Li, Edward O Bixler
{"title":"Effect of age on the association of obstructive sleep apnea with metabolic syndrome among obese and nonobese adults.","authors":"Slobodanka Pejovic, Alexandros N Vgontzas, Julio Fernandez-Mendoza, Fan He, Yun Li, Edward O Bixler","doi":"10.5664/jcsm.11698","DOIUrl":"10.5664/jcsm.11698","url":null,"abstract":"<p><strong>Study objectives: </strong>It has been described a bi-directional association between obstructive sleep apnea (OSA) and metabolic syndrome (MetS), both promoting atherosclerosis and cardiovascular disease. Given that cardiometabolic comorbidities associated with OSA tend to diminish with age, in this study we examined whether the association of OSA with MetS is modified by age and body weight.</p><p><strong>Methods: </strong>We studied 1,741 adults from the Penn State Adult Cohort (age 20-88 years) who underwent a 1-night polysomnography, clinical history, and physical examination in a cross-sectional design. The presence of OSA was defined as an apnea-hypopnea index ≥ 15 events/h. Outcome variables include the 5 MetS components (obesity [≥ 30kg/m<sup>2</sup>], hypertension [≥ 130/85 mm Hg], hyperglycemia [fasting blood sugar (FBS) ≥ 100 mg/dL], hypercholesterolemia [≥ 200 mg/dL], and hypertriglyceridemia [≥ 150 mg/dL]). Logistic regression models examined the association of OSA with MetS components adjusting for confounders.</p><p><strong>Results: </strong>There was a significant interaction between OSA and age on MetS. In young and middle-aged individuals (< 60 years old) but not in older individuals, OSA was significantly associated with MetS and its individual components, ie, hypertension (odds ratio [OR] = 3.85, 95% confidence interval [CI] = 1.95-7.63), hyperglycemia (OR = 5.62, 95% CI = 2.74-11.53), hypercholesterolemia (OR = 5.99, 95% CI = 2.36-15.21), and hypertriglyceridemia (OR = 4.75, 95% CI = 2.30-9.90). The association of OSA with body mass index was stronger in the young and middle-aged vs older group (OR = 6.03, 95% CI = 3.08-11.78 vs 2.47, 95% CI = 1.23-4.94, respectively). Similar age-related modifications were observed in nonobese individuals.</p><p><strong>Conclusions: </strong>The strong association of OSA with MetS in young and middle-aged obese and nonobese adults, but not in older adults, suggests that MetS is key to the pathogenesis of OSA in young and middle-aged adults and should be a treatment priority.</p><p><strong>Citation: </strong>Pejovic S, Vgontzas AN, Fernandez-Mendoza J, He F, Li Y, Bixler EO. Effect of age on the association of obstructive sleep apnea with metabolic syndrome among obese and nonobese adults. <i>J Clin Sleep Med</i>. 2025;21(8):1371-1378.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1371-1378"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320680/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143755610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lourdes M DelRosso, Harshill Modi, Viraj Jain, Itzel M Vazquez, Daniel L Picchietti
{"title":"Residual periodic limb movement index after CPAP therapy is associated with hypoxemia.","authors":"Lourdes M DelRosso, Harshill Modi, Viraj Jain, Itzel M Vazquez, Daniel L Picchietti","doi":"10.5664/jcsm.11716","DOIUrl":"10.5664/jcsm.11716","url":null,"abstract":"<p><strong>Study objectives: </strong>Periodic limb movements during sleep frequently coexist with obstructive sleep apnea, yet the impact of continuous positive airway pressure treatment on periodic limb movements during sleep remains unclear. This study investigated factors associated with persistence of periodic limb movement index (PLMI) during continuous positive airway pressure therapy.</p><p><strong>Methods: </strong>A retrospective cross-sectional study analyzed data from 107 adult patients who underwent split polysomnographic studies. Participants were classified into 4 groups based on PLMI changes: normal PLMI throughout (group 1), persistent elevated PLMI (group 2), worsened PLMI (group 3), and resolved PLMI (group 4). Predictors of PLMI persistence, including sleep architecture, oxygen desaturation, age, and body mass index, were assessed using logistic regression analysis.</p><p><strong>Results: </strong>36.1% of patients experienced resolution of elevated PLMI, 16.4% showed worsening, and 47.5% had persistent PLMI despite continuous positive airway pressure therapy. Logistic regression analysis revealed that male sex (odds ratio = 5.38, 95% confidence interval = 1.64-17.61, <i>P =</i> .005), higher body mass index (odds ratio = 1.09, 95% confidence interval = 1.01-1.17, <i>P =</i> .018), and greater time spent with oxygen saturation ≤ 88% during the diagnostic portion (odds ratio = 1.034, 95% confidence interval = 1.002-1.066, <i>P =</i> .035) were significant predictors of residual PLMI. Sleep architecture variables such as total sleep time, sleep efficiency, and sleep stage distribution were not independently associated with residual PLMI.</p><p><strong>Conclusions: </strong>Residual periodic limb movements during continuous positive airway pressure therapy are common and are independently associated with male sex, higher body mass index, and greater hypoxemia during the diagnostic portion of sleep.</p><p><strong>Citation: </strong>DelRosso LM, Modi H, Jain V, Vazquez IM, Picchietti DL. Residual periodic limb movement index after CPAP therapy is associated with hypoxemia. <i>J Clin Sleep Med</i>. 2025;21(8):1389-1393.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1389-1393"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320682/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996572","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Age matters: the differential impact of OSA on metabolic health by age group.","authors":"Mehrnaz Azarian","doi":"10.5664/jcsm.11796","DOIUrl":"10.5664/jcsm.11796","url":null,"abstract":"","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1335-1336"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144227437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna M Mohammadieh, Benjamin K Tong, Glenn M Stewart, Philip de Chazal, Peter A Cistulli
{"title":"Evaluation of a novel smart mandibular advancement device for nightly monitoring of treatment.","authors":"Anna M Mohammadieh, Benjamin K Tong, Glenn M Stewart, Philip de Chazal, Peter A Cistulli","doi":"10.5664/jcsm.11736","DOIUrl":"10.5664/jcsm.11736","url":null,"abstract":"<p><strong>Study objectives: </strong>A current gap in oral appliance therapy, relative to continuous positive airway pressure, in the management of obstructive sleep apnea is access to nightly therapy data. The aim of this pilot study was to evaluate the performance of a novel intraoral, multisensory array embedded within a mandibular advancement device (MAD).</p><p><strong>Methods: </strong>Patients established on MAD therapy for obstructive sleep apnea underwent 2 level 2 diagnostic polysomnography (PSG) studies with the smart MAD (sMAD) in situ, under 0 protrusion (control) and usual mandibular protrusion (treatment) conditions. The studies occurred within 2 weeks of one another, and the sequence of studies was randomly allocated. The agreement between sMAD and PSG was assessed using apnea-hypopnea index (AHI), total sleep time, and sleep position. An additional aim was to assess the ability of the device to detect the change in AHI across the 2 conditions (control vs treatment).</p><p><strong>Results: </strong>Overall, there was a high level of agreement between sMAD and PSG in the treatment condition with regards to the AHI (<i>r</i> = .81, <i>P</i> < .001). Both PSG and sMAD detected a significant change in AHI associated with mandibular advancement in the treatment condition relative to control, and this change was not significantly different between the 2 (-12.7 ± 13.8 vs -6.9 ± 8.5 events/h for PSG and sMAD, respectively, <i>P</i> = .1). There was a high level of agreement for total sleep time in the combined control and treatment groups (<i>r</i> = .80, <i>P</i> < .001). Sleep position showed high concordance in the lateral position (98%), but supine sleep showed moderate concordance (64%) related to differences in position monitoring between sMAD and PSG (ie, head vs torso).</p><p><strong>Conclusions: </strong>This pilot study demonstrates the feasibility of estimating clinically relevant therapy data with high accuracy from a sensor system within a MAD. The ability to provide clinicians with relevant sleep metrics including AHI, total sleep time, adherence, sleep position, and response to MAD therapy on a nightly basis has the potential to enhance clinical uptake of MAD therapy. Further research is required to validate these results in a larger sample over a longer term.</p><p><strong>Citation: </strong>Mohammadieh AM, Tong BK, Stewart GM, de Chazal P, Cistulli PA. Evaluation of a novel smart mandibular advancement device for nightly monitoring of treatment. <i>J Clin Sleep Med</i>. 2025;21(8):1425-1432.</p>","PeriodicalId":50233,"journal":{"name":"Journal of Clinical Sleep Medicine","volume":" ","pages":"1425-1432"},"PeriodicalIF":2.9,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12320676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}