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临床试验/NCT07182617
NCT07182617已完成不适用

Assessing the Utility of a Remote Patient Monitoring Platform for Improving CPAP Adherence for Obstructive Sleep Apnea

MonitAir2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年2月5日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
CPAP adherence according to Medicare criteria

研究概览

简要总结

This study tested whether using the MonitAir remote patient monitoring (RPM) platform could improve adherence to continuous positive airway pressure (CPAP) therapy for patients with obstructive sleep apnea. Patients starting CPAP treatment with BetterNight were randomized to receive either standard coaching (control group) or enhanced monitoring with the MonitAir platform (intervention group). The study measured CPAP adherence at 30, 60, and 90 days, as well as patient satisfaction and other clinical outcomes.

详细描述

Obstructive sleep apnea (OSA) is a highly prevalent sleep disorder that is associated with hypertension, cardiovascular disease, diabetes, and impaired quality of life. Continuous positive airway pressure (CPAP) therapy is the gold standard treatment for OSA, but long-term adherence remains a significant challenge. Many patients discontinue therapy early, and overall adherence rates often fall below the thresholds required for symptom relief and insurance coverage.

Remote patient monitoring (RPM) has been successfully applied to other chronic diseases such as heart failure, diabetes, and asthma, improving both patient engagement and clinical outcomes. MonitAir is a HIPAA-compliant, FDA-registered Medical Device Data System (MDDS) designed to integrate CPAP device data with telehealth features, enabling clinicians to remotely track nightly usage, apnea-hypopnea index (AHI), and mask leak, while providing timely feedback and support to patients.

This randomized controlled trial was conducted in partnership with BetterNight, a nationwide provider of sleep services. A total of 200 patients with newly diagnosed OSA who were initiating CPAP therapy were randomized in a 1:1 ratio to receive either the standard BetterNight coaching program (standard of care arm) or the same program enhanced with the MonitAir RPM platform (intervention arm). The MonitAir arm included structured weekly data reviews, automated text messaging, monthly telehealth check-ins, and physician escalation when clinically indicated.

The primary outcome was CPAP adherence at 30, 60, and 90 days, defined according to Medicare criteria (≥4 hours of CPAP use per night for at least 70 percent of nights in a consecutive 30-day period). Secondary outcomes included patient satisfaction, time to reach CMS adherence, average nightly CPAP use, validated sleep quality questionnaires (FOSQ, PSQI, ESS), residual AHI, mask leak, mask on/off events, the number of mask refits, and study dropout rates with reasons.

Each patient participated for 90 days, and interim analysis was planned once 150 patients had been enrolled. Safety monitoring included routine tracking of typical CPAP side effects such as nasal dryness, rhinorrhea, facial irritation, or infection. Because all patients received CPAP therapy, no excess risks were anticipated between study arms; the only difference was the method of monitoring.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ≥18 years old
  • Access to a smartphone (iOS or Android)
  • Ability to engage in two-way text communication and audiovisual conferencing
  • Home sleep test (HST) or polysomnogram (PSG) performed ≤90 days before randomization
  • Apnea-Hypopnea Index (AHI) ≥5 (using 3% desaturation criteria)
  • Prescribed and willing to initiate CPAP or APAP therapy
  • Receiving a ResMed, Philips, or React CPAP device with a cellular modem
  • CPAP data available to MonitAir and BetterNight

排除标准

  • Department of Transportation (DOT) drivers
  • Central sleep apnea or Cheyne-Stokes respirations (CSA/CSR) ≥10% of diagnostic study
  • Central or mixed apneas ≥25% of AHI
  • Use of BiPAP, BiPAP ST, ASV, AVAPS, or any other non-invasive ventilation modality
  • Inability or unwillingness to participate in study activities or meet requirements

结局指标

主要结局

CPAP adherence according to Medicare criteria

时间窗: Days 30, 60, and 90 after CPAP initiation

Percentage of patients meeting Medicare adherence criteria, defined as ≥4 hours of CPAP use per night for ≥70% of nights in a consecutive 30-day period, measured at 30, 60, and 90 days.

次要结局

  • Patient Satisfaction(Baseline, Day 30, Day 60, and Day 90 after starting CPAP)
  • Time to CMS-defined adherence(Baseline to Day 90 after starting CPAP)
  • Average nightly CPAP use(Day 30, Day 60, and Day 90 after starting CPAP)
  • Functional Outcomes of Sleep Questionnaire (FOSQ)(Baseline, Day 30, Day 60, and Day 90 after starting CPAP)
  • Pittsburgh Sleep Quality Index (PSQI)(Baseline, Day 30, Day 60, and Day 90 after starting CPAP)
  • Epworth Sleepiness Scale (ESS)(Baseline, Day 30, Day 60, and Day 90 after starting CPAP)
  • Residual Apnea-Hypopnea Index (AHI)(Baseline and Day 90 or at Medicare adherence assessment)
  • Mask leak(Day 30, Day 60, and Day 90 after starting CPAP)
  • Mask on/off events(Day 30, Day 60, and Day 90 after starting CPAP)
  • Mask refits(Up through Day 90 after starting CPAP)
  • Study dropout rate(Up through Day 90 after starting CPAP)

研究者

发起方
MonitAir
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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