MonitAir Remote Patient Monitoring Versus Standard of Care for CPAP Adherence in Obstructive Sleep Apnea (MONITAIR-OSA)

MonitAir

Status: Completed

Conditions: Obstructive Sleep Apnea (OSA)

Treatments: Behavioral: Standard Coaching (SOC); Behavioral: MonitAir RPM

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07182617

MONITAIR-CPAP-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Standard of Care (SOC) Coaching

Active Comparator group

Description:

Participants received the standard BetterNight coaching program for CPAP initiation and adherence. Monitoring was performed using existing systems (ResMed AirView, Philips Care Orchestrator, and the internal Clarity dashboard). Coaches contacted patients at scheduled checkpoints (10, 20, 45, 60, and 80 days) and provided support as needed to help patients meet Medicare adherence criteria.

Treatment:

Behavioral: Standard Coaching (SOC)

MonitAir Remote Patient Monitoring (RPM)

Experimental group

Description:

Participants received the standard BetterNight coaching program enhanced with the MonitAir RPM platform. MonitAir enabled weekly data reviews, automated text reminders, and at least one interactive telehealth session per month. Alerts for poor adherence, high residual AHI, or mask issues triggered outreach by coaches and escalation to physicians when needed. The goal was to improve CPAP adherence and patient satisfaction through continuous digital monitoring and engagement.

Treatment:

Behavioral: MonitAir RPM