Obstructive Sleep Apnea (OSA)MONITAIR-OSANCT07182617
MonitAir Remote Patient Monitoring Versus Standard of Care for CPAP Adherence in Obstructive Sleep Apnea
A study testing Standard Coaching (SOC) and MonitAir RPM in people with Obstructive Sleep Apnea (OSA), run by MonitAir at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Standard Coaching (SOC) and MonitAir RPM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Utility of a Remote Patient Monitoring Platform for Improving CPAP Adherence for Obstructive Sleep Apnea
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.
Read the 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)
- Being tested
- Standard Coaching (SOC), MonitAir RPM
- Keywords
- Sleep Apnea, Obstructive Sleep Apnea, OSA, CPAP, CPAP Adherence, Remote Patient Monitoring, Telehealth, Digital Health, Patient Engagement
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Coaching (SOC)Behavioural
Also called BetterNight Standard of Care
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 RPMBehavioural
Also called MonitAir Remote Patient Monitoring
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: MonitAir RPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 30, 60, and 90 after CPAP initiation
Secondary outcomes (11)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up through Day 90 after starting CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start5 Feb 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two parallel arms: standard coaching program (SOC) versus MonitAir remote patient monitoring (RPM) platform.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MonitAir
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BetterNight
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182617
- Sponsor's protocol ID
- MONITAIR-CPAP-001
- Acronym
- MONITAIR-OSA
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data (IPD). Aggregate study results will be published in peer-reviewed journals and may be presented at conferences.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of a Remote Patient Monitoring Platform for Improving CPAP Adherence for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07182617
- Acronym / sponsor ID
- MONITAIR-OSA / MONITAIR-CPAP-001
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- Sleep Apnea, Obstructive Sleep Apnea, OSA, CPAP, CPAP Adherence, Remote Patient Monitoring, Telehealth, Digital Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- MonitAirIndustry (pharma, biotech, devices)
- Collaborators
- BetterNight
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two parallel arms: standard coaching program (SOC) versus MonitAir remote patient monitoring (RPM) platform.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) Coaching | Active comparator | Behavioral: Standard Coaching (SOC)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. |
| MonitAir Remote Patient Monitoring (RPM) | Experimental | Behavioral: MonitAir RPMParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Coaching (SOC)Also: BetterNight Standard of CareParticipants 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. | Behavioural | Standard of Care (SOC) Coaching |
| MonitAir RPMAlso: MonitAir Remote Patient MonitoringParticipants 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. | Behavioural | MonitAir Remote Patient Monitoring (RPM) |
Primary outcome
CPAP adherence according to Medicare criteria
Time frame: 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.
11 secondary outcomes
Patient Satisfaction
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Time to CMS-defined adherence
Time frame: Baseline to Day 90 after starting CPAP
Average nightly CPAP use
Time frame: Day 30, Day 60, and Day 90 after starting CPAP
Functional Outcomes of Sleep Questionnaire (FOSQ)
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Epworth Sleepiness Scale (ESS)
Time frame: Baseline, Day 30, Day 60, and Day 90 after starting CPAP
Residual Apnea-Hypopnea Index (AHI)
Time frame: Baseline and Day 90 or at Medicare adherence assessment
Mask leak
Time frame: Day 30, Day 60, and Day 90 after starting CPAP
Mask on/off events
Time frame: Day 30, Day 60, and Day 90 after starting CPAP
Mask refits
Time frame: Up through Day 90 after starting CPAP
Study dropout rate
Time frame: Up through Day 90 after starting CPAP
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data (IPD). Aggregate study results will be published in peer-reviewed journals and may be presented at conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Coaching (SOC) and MonitAir RPM in people with Obstructive Sleep Apnea (OSA), run by MonitAir at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP adherence according to Medicare criteria (time frame: Days 30, 60, and 90 after CPAP initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.