TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2026-03-01 Epub Date: 2026-02-04 DOI:10.1016/j.cct.2026.108252

Emerson M. Wickwire , Vincent F. Capaldi II , Jennifer Y. So , Eungjae Kim , Connie Thomas , Christine W. Johnston , Sarah Maggio , Joshua S. Elmore , Jennifer S. Albrecht , Avelino C. Verceles , Shuo Chen

{"title":"TELE-SLEEP OSA: A protocol for a hybrid type I randomized clinical trial of telemedicine for obstructive sleep apnea among military dependents and retirees","authors":"Emerson M. Wickwire , Vincent F. Capaldi II , Jennifer Y. So , Eungjae Kim , Connie Thomas , Christine W. Johnston , Sarah Maggio , Joshua S. Elmore , Jennifer S. Albrecht , Avelino C. Verceles , Shuo Chen","doi":"10.1016/j.cct.2026.108252","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Obstructive sleep apnea (OSA) is common and costly in the U.S. military health system (MHS). OSA is associated with poor health outcomes as well as increased economic burden borne by the Defense Health Agency. The MHS lacks the capacity to meet the available demand for sleep specialty care. Thus, most military OSA care is provided by private sector TRICARE-contracted civilian providers. Given the burden of OSA and limited access to OSA care, optimizing OSA care within the MHS is vital. TELE-SLEEP OSA is a randomized, parallel group, single blind, controlled clinical trial comparing OSA telehealth care to standard private sector TRICARE.</div></div><div><h3>Methods</h3><div>Participants will include 160 active-duty family members and Defense Enrollment Eligibility Reporting System beneficiaries who are referred for OSA consultation. Following informed consent, participants will complete baseline assessments prior to randomization. Participants randomized to private sector TRICARE will receive treatment as usual, including positive airway pressure (PAP) therapy. Participants randomized to OSA telehealth care will undergo telehealth consultation with a board-certified sleep medicine specialist, undergo home sleep apnea testing, receive auto-titrating PAP therapy, and receive ongoing support from educator-level sleep navigators throughout the study. Quantitative follow-up assessments will be completed at 30 and 90 days after treatment initiation. Qualitative focus groups to assess participant satisfaction and other implementation outcomes will be conducted with participants from both treatment groups. Outcomes include PAP adherence (primary outcome), OSA symptoms, implementation, and cost-effectiveness.</div></div><div><h3>Conclusion</h3><div>Our telemedicine approach to OSA treatment aims to reduce costs and improve health outcomes within the MHS.</div></div><div><h3>Clinical trial registration</h3><div><span><span>NCT07121452</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"162 ","pages":"Article 108252"},"PeriodicalIF":1.9000,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary clinical trials","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1551714426000388","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2026/2/4 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Obstructive sleep apnea (OSA) is common and costly in the U.S. military health system (MHS). OSA is associated with poor health outcomes as well as increased economic burden borne by the Defense Health Agency. The MHS lacks the capacity to meet the available demand for sleep specialty care. Thus, most military OSA care is provided by private sector TRICARE-contracted civilian providers. Given the burden of OSA and limited access to OSA care, optimizing OSA care within the MHS is vital. TELE-SLEEP OSA is a randomized, parallel group, single blind, controlled clinical trial comparing OSA telehealth care to standard private sector TRICARE.

Methods

Participants will include 160 active-duty family members and Defense Enrollment Eligibility Reporting System beneficiaries who are referred for OSA consultation. Following informed consent, participants will complete baseline assessments prior to randomization. Participants randomized to private sector TRICARE will receive treatment as usual, including positive airway pressure (PAP) therapy. Participants randomized to OSA telehealth care will undergo telehealth consultation with a board-certified sleep medicine specialist, undergo home sleep apnea testing, receive auto-titrating PAP therapy, and receive ongoing support from educator-level sleep navigators throughout the study. Quantitative follow-up assessments will be completed at 30 and 90 days after treatment initiation. Qualitative focus groups to assess participant satisfaction and other implementation outcomes will be conducted with participants from both treatment groups. Outcomes include PAP adherence (primary outcome), OSA symptoms, implementation, and cost-effectiveness.

Conclusion

Our telemedicine approach to OSA treatment aims to reduce costs and improve health outcomes within the MHS.

Clinical trial registration

NCT07121452.

查看原文本刊更多论文

远程睡眠呼吸暂停：一项混合I型随机远程医疗治疗军人家属和退休人员阻塞性睡眠呼吸暂停的临床试验方案。

背景：阻塞性睡眠呼吸暂停（OSA）在美国军事卫生系统（MHS）中是常见且昂贵的。阻塞性睡眠呼吸暂停与不良的健康结果以及国防卫生机构所承担的经济负担增加有关。MHS缺乏满足睡眠专业护理需求的能力。因此，大多数军事OSA护理是由私营部门tricare合同的民用供应商提供的。鉴于阻塞性睡眠呼吸暂停的负担和获得阻塞性睡眠呼吸暂停治疗的机会有限，在MHS内优化阻塞性睡眠呼吸暂停治疗至关重要。TELE-SLEEP OSA是一项随机、平行组、单盲、对照临床试验，比较OSA远程医疗与标准私营部门TRICARE。方法：参与者将包括160名现役家庭成员和国防登记资格报告系统受益人，他们被转介进行OSA咨询。根据知情同意，参与者将在随机化之前完成基线评估。随机分配到私营TRICARE的参与者将照常接受治疗，包括气道正压（PAP）治疗。随机分配到OSA远程医疗的参与者将接受委员会认证的睡眠医学专家的远程医疗咨询，接受家庭睡眠呼吸暂停测试，接受自动滴定PAP治疗，并在整个研究过程中接受教育级睡眠导航员的持续支持。定量随访评估将在治疗开始后30和90 天完成。定性焦点小组将对来自两个治疗组的参与者进行评估，以评估参与者满意度和其他实施结果。结局包括PAP依从性（主要结局）、OSA症状、实施和成本-效果。结论：我们的远程医疗方法治疗阻塞性睡眠呼吸暂停旨在降低成本，改善MHS内的健康结果。临床试验注册：NCT07121452。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.