Obstructive Sleep ApneaNCT07898254
Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy
A study testing Dynamic cMAP and Direct cMAP in people with Obstructive Sleep Apnea, run by NovaResp Technologies Inc at 1 site in Canada.
Trial summary
The goal of this clinical trial is to identify which settings of proactive therapy work best in OSA patients who regularly adhere to PAP therapy at home. The main question(s) it aims to answer are: To assess how different settings of proactive therapy affect therapy effectiveness To assess whether proactive therapy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Dynamic cMAP and Direct cMAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 30 Nov 2027to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Must have a diagnosis of OSA (AHI ≥ 5), with central events less than 50% of all events.
- Must have used a PAP device for more than 4 months.
- Must use PAP therapy for more than 4 hours per night.
- Must have a median therapy pressure between 6 and 20 cmH₂O.
- Must be able to operate the study devices at home and wear the sleep diagnostic ring each night.
- be able to understand English and give written informed consent.
Who cannot join
- Subjects actively using bi-level PAP or require oxygen therapy.
- Excess leak (greater than 24 L/min) for more than 10% of the time on therapy.
- Known treatment-emergent or complex central sleep apnea.
- Significant or unstable cardiovascular, respiratory, neurological, or psychiatric disease.
- Any condition that, in the opinion of the clinician, makes unsupervised home use unsafe.
- Neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, New York Heart Association class III or IV heart failure, recent myocardial infarction or severe cardiac arrhythmias, or persistent uncontrolled hypertension despite medication use.
- Pregnancy, planning to become pregnant, or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
NovaResp Technologies Inc.
Halifax, Nova Scotia, B3H 4H5
Megan Neil, BScN, 902-986-1660, megan.neil@novaresp.com
Kaitlyn Dicks, BSc, 902-809-1543, kaitlyn@novaresp.com
About this study
Official title: Experimental Evaluation of cMAP® Therapy Parameters Delivered Through Commercial Positive Airway Pressure (PAP) Devices in Adults Using PAP Therapy at Home
The goal of this clinical trial is to identify which settings of proactive therapy work best in OSA patients who regularly adhere to PAP therapy at home. The main question(s) it aims to answer are:
- To assess how different settings of proactive therapy affect therapy effectiveness
- To assess whether proactive therapy works similarly across different PAP devices Participants will undergo conventional APAP therapy and two modes of proactive therapy on two different PAP devices.
Nights in which conventional APAP was used and nights in which proactive therapy was used to see which settings treated patients most effectively.
Read the detailed description
This is a single-arm, single-blinded, non-randomised, within-subject study on patients diagnosed with obstructive sleep apnea who regularly adhere to PAP therapy. Data collection will span 6 to 8 months for each participant at home. Participants will use two of three modified PAP devices for at least 12 weeks each. Each device period is divided into 7-day therapy blocks, starting with conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) to establish a baseline, followed by blocks of proactive therapy, with a repeat APAP block midway. Proactive therapy is delivered in two modes: a) Dynamic cMAP®, where AI predictions guide adjustable therapy settings, and b) Direct cMAP®, where AI sets the therapy pressure directly. Therapy settings may be refined between blocks as data are collected, and pressure is always limited by independent safety limits. Participants will be blinded to the therapy they are receiving. Data will be collected by the modified PAP device and at-home sleep apnea test ring.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Dynamic cMAP, Direct cMAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dynamic cMAPDevice
Uses AI to make predictions of future apneic events. A deterministic algorithm uses output predictions to determine pressure.
Direct cMAPDevice
Uses AI to directly determine the therapy pressure to prevent future apneic events
| Study group | Role | What they receive |
|---|---|---|
| Proactive Therapy | Experimental | On each of two PAP devices, patients will undergo conventional APAP therapy first, followed by blocks of proactive therapy, with a repeat APAP block midway. Receives: Device: Dynamic cMAP; Device: Direct cMAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Calculated as the mean number of apnea and hypopnea events throughout the night, in events/hr. AHI= total number of apnea events+ total number of hypopnea events/total sleep time (hours).
Normal: <5 events per hour Mild Sleep Apnea: 5 to 14.9 events per hour Moderate Sleep Apnea: 15 to 29.9 events per hour Severe Sleep Apnea: >30 events per hour
Measured: 6-8 months
Secondary outcomes (3)
Oxygen Saturation
Calculated as the mean blood oxygen saturation throughout the night, in percentage. This is completed by using an FDA approved wearable ring that uses cardiopulmonary coupling for the measurement of blood oxygen saturation.
95-100% is healthy for adults 90%-94% is low/borderline <90% Clinically low/Hypoxemia
Measured: 6-8 months
Sleep quality
Sleep quality is calculated using heart rate variability (HRV), sleep efficiency, and sleep fragmentation which is measured throughout the night. These measurements are calculated by using an FDA approved wearable ring that uses cardiopulmonary coupling, resulting in the measurement of sleep quality.
Sleep quality is measure in percentage.
Measured: 6-8 months
Mask Pressure
Calculated as the mean pressure throughout the night.
Measured: 6-8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start30 Nov 2027 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaResp Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898254
- Sponsor's protocol ID
- Home CPAP Testing
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Evaluation of cMAP® Therapy Parameters Delivered Through Commercial Positive Airway Pressure (PAP) Devices in Adults Using PAP Therapy at Home
- ClinicalTrials.gov ID
- NCT07898254
- Acronym / sponsor ID
- Home CPAP Testing
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NovaResp Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2027 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 27 Oct 2026 (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.
The goal of this clinical trial is to identify which settings of proactive therapy work best in OSA patients who regularly adhere to PAP therapy at home. The main question(s) it aims to answer are:
- To assess how different settings of proactive therapy affect therapy effectiveness
- To assess whether proactive therapy works similarly across different PAP devices Participants will undergo conventional APAP therapy and two modes of proactive therapy on two different PAP devices.
Nights in which conventional APAP was used and nights in which proactive therapy was used to see which settings treated patients most effectively.
Detailed description
This is a single-arm, single-blinded, non-randomised, within-subject study on patients diagnosed with obstructive sleep apnea who regularly adhere to PAP therapy. Data collection will span 6 to 8 months for each participant at home. Participants will use two of three modified PAP devices for at least 12 weeks each. Each device period is divided into 7-day therapy blocks, starting with conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) to establish a baseline, followed by blocks of proactive therapy, with a repeat APAP block midway. Proactive therapy is delivered in two modes: a) Dynamic cMAP®, where AI predictions guide adjustable therapy settings, and b) Direct cMAP®, where AI sets the therapy pressure directly. Therapy settings may be refined between blocks as data are collected, and pressure is always limited by independent safety limits. Participants will be blinded to the therapy they are receiving. Data will be collected by the modified PAP device and at-home sleep apnea test ring.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proactive Therapy | Experimental | Device: Dynamic cMAP, Device: Direct cMAPOn each of two PAP devices, patients will undergo conventional APAP therapy first, followed by blocks of proactive therapy, with a repeat APAP block midway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must have a diagnosis of OSA (AHI ≥ 5), with central events less than 50% of all events.
- Must have used a PAP device for more than 4 months.
- Must use PAP therapy for more than 4 hours per night.
- Must have a median therapy pressure between 6 and 20 cmH₂O.
- Must be able to operate the study devices at home and wear the sleep diagnostic ring each night.
Key exclusion criteria (7 listed)
- Subjects actively using bi-level PAP or require oxygen therapy.
- Excess leak (greater than 24 L/min) for more than 10% of the time on therapy.
- Known treatment-emergent or complex central sleep apnea.
- Significant or unstable cardiovascular, respiratory, neurological, or psychiatric disease.
- Any condition that, in the opinion of the clinician, makes unsupervised home use unsafe.
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 |
|---|---|---|
| Dynamic cMAPUses AI to make predictions of future apneic events. A deterministic algorithm uses output predictions to determine pressure. | Device | Proactive Therapy |
| Direct cMAPUses AI to directly determine the therapy pressure to prevent future apneic events | Device | Proactive Therapy |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 6-8 months
Calculated as the mean number of apnea and hypopnea events throughout the night, in events/hr. AHI= total number of apnea events+ total number of hypopnea events/total sleep time (hours). Normal: <5 events per hour Mild Sleep Apnea: 5 to 14.9 events per hour Moderate Sleep Apnea: 15 to 29.9 events per hour Severe Sleep Apnea: >30 events per hour
3 secondary outcomes
Oxygen Saturation
Time frame: 6-8 months
Sleep quality
Time frame: 6-8 months
Mask Pressure
Time frame: 6-8 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
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A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
Subjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dynamic cMAP and Direct cMAP in people with Obstructive Sleep Apnea, run by NovaResp Technologies Inc at 1 site in Canada.
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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 27 Oct 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Neil, BScN (902-986-1660, megan.neil@novaresp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: 6-8 months). 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 27 Oct 2026.