MonitAir Remote Patient Monitoring Versus Standard of Care for CPAP Adherence in Obstructive Sleep Apnea

NCT ID: NCT07182617

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-05
• Study Completion Date: 2025-04-01

Brief Summary

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.

Detailed 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.

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC) Coaching

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.

Group Type: ACTIVE_COMPARATOR

Standard Coaching (SOC)

Intervention Type: BEHAVIORAL

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.

MonitAir Remote Patient Monitoring (RPM)

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.

Group Type: EXPERIMENTAL

MonitAir RPM

Intervention Type: BEHAVIORAL

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.

Interventions

Standard Coaching (SOC)

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.

Intervention Type: BEHAVIORAL

MonitAir RPM

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

BetterNight Standard of Care; MonitAir Remote Patient Monitoring

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BetterNight

UNKNOWN

Sponsor Role: collaborator

MonitAir

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Remote

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Study Documents

Document Type: Study Protocol

https://drive.google.com/file/d/1Y8Ubu5Ie\_BSDOER7\_672YlAa5KttK5Wn/view?usp=sharing

View Document

Other Identifiers

MONITAIR-CPAP-001

Identifier Type: -

Identifier Source: org_study_id