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

NCT07182617 | Completed

• 1 other identifier: MONITAIR-CPAP-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

Sleep Apnea; Obstructive Sleep Apnea; OSA; CPAP; CPAP Adherence; Remote Patient Monitoring; Telehealth; Digital Health; Patient Engagement

Outcome Measures

Primary Outcomes (1)

• 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.

  Days 30, 60, and 90 after CPAP initiation

Secondary Outcomes (11)

• 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

Study Arms (2)

Standard of Care (SOC) Coaching

ACTIVE COMPARATOR

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.

Behavioral: Standard Coaching (SOC)

MonitAir Remote Patient Monitoring (RPM)

EXPERIMENTAL

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.

Behavioral: MonitAir RPM

Interventions

Standard Coaching (SOC) 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.

Also known as: BetterNight Standard of Care

Standard of Care (SOC) Coaching

MonitAir RPM 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.

Also known as: MonitAir Remote Patient Monitoring

MonitAir Remote Patient Monitoring (RPM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MonitAir: lead
• BetterNight: collaborator

Study Sites (1)

Remote

Miami, Florida, 33176, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Patient Participation

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two parallel arms: standard coaching program (SOC) versus MonitAir remote patient monitoring (RPM) platform.

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 19, 2025
• Study Start: February 5, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)