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.
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.
Participants received BetterNight's standard CPAP coaching program. Monitoring was conducted through manufacturer platforms (ResMed AirView, Philips Care Orchestrator) and BetterNight's internal Clarity dashboard. Coaches contacted patients at scheduled checkpoints (10, 20, 45, 60, and 80 days) to provide education, support, and troubleshooting to help patients achieve Medicare adherence.
Participants received the standard BetterNight coaching program enhanced with the MonitAir remote patient monitoring platform. MonitAir enabled weekly reviews of CPAP usage data, automated text follow-ups, and at least one interactive telehealth visit per month. Coaches escalated issues such as poor adherence, high residual AHI, or mask leak to physicians as needed. The intervention aimed to improve CPAP adherence and patient satisfaction compared with standard care.
Remote
Miami, Florida, United States
CPAP adherence according to Medicare criteria
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.
Time frame: Days 30, 60, and 90 after CPAP initiation
Patient Satisfaction
Patient satisfaction with therapy measured using a 5-point Likert scale (1 = very dissatisfied; 5 = very satisfied). Higher scores reflect greater satisfaction. Administered via electronic survey.
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Time to CMS-defined adherence
Number of days required for each participant to meet CMS adherence criteria: ≥4 hours/night on ≥70% of nights in a consecutive 30-day period within the first 90 days. Lower values indicate faster adherence achievement.
Time frame: Baseline to Day 90 after starting CPAP
Average nightly CPAP use
Mean CPAP use in hours per night, calculated separately for all days and for days with usage, based on device-recorded data. Higher values indicate greater adherence to therapy.
Time frame: Day 30, Day 60, and Day 90 after starting CPAP
Functional Outcomes of Sleep Questionnaire (FOSQ)
Sleep-related quality of life measured by the FOSQ-10. Total score range: 5 (worst) to 20 (best). Higher scores indicate better functional outcomes related to sleep.
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Pittsburgh Sleep Quality Index (PSQI)
Patient-reported global sleep quality using PSQI. Total score range: 0 to 21. Higher scores indicate worse sleep quality. Administered via electronic survey.
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Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Epworth Sleepiness Scale (ESS)
Daytime sleepiness measured by the ESS. Total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Residual Apnea-Hypopnea Index (AHI)
Mean residual AHI (events/hour) captured from CPAP device while on therapy. AHI reflects apneas and hypopneas per hour of use. Lower values indicate better treatment effectiveness.
Time frame: Baseline and Day 90 or at Medicare adherence assessment
Mask leak
Median mask leak (liters per minute) per participant as recorded by CPAP device. Lower values reflect better mask seal and improved therapy delivery.
Time frame: Day 30, Day 60, and Day 90 after starting CPAP
Mask on/off events
Mean number of times per night the CPAP mask is removed and reapplied, as recorded by the device. Lower values reflect better comfort and sleep continuity.
Time frame: Day 30, Day 60, and Day 90 after starting CPAP
Mask refits
Number of mask refitting events performed per participant during the study, as recorded by clinical staff. Fewer refits may reflect better initial fit and mask comfort.
Time frame: Up through Day 90 after starting CPAP
Study dropout rate
Proportion of participants who withdrew from the study. Reasons for dropout (e.g., discomfort, non-adherence, lost to follow-up) will be recorded and categorized.
Time frame: Up through Day 90 after starting CPAP