ClinicalTrials.gg
Not yet recruitingNCT07898254Updated Oct 27, 2026

Testing Settings of NovaResp's cMAP® Software During Home PAP Therapy

An interventional study of Dynamic cMAP and Direct cMAP in Obstructive Sleep Apnea, sponsored by NovaResp Technologies Inc. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by NovaResp Technologies Inc · Not applicable, Interventional, and Treatment

Updated Oct 27, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,266 studies on the registry are indexed under Sleep Apnea, Obstructive; 468 are open to participants now.

This study's planned enrollment of 50 is close to the median of 53 across 1,492 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

NovaResp Technologies Inc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Proactive Therapy

    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.

    Device: Dynamic cMAP · Device: Direct cMAP

Interventions

  • DeviceDynamic cMAP

    Uses AI to make predictions of future apneic events. A deterministic algorithm uses output predictions to determine pressure.

  • DeviceDirect cMAP

    Uses AI to directly determine the therapy pressure to prevent future apneic events

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 6-8 months

Secondary outcomes

  1. 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

    Time frame: 6-8 months

  2. 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.

    Time frame: 6-8 months

  3. Mask Pressure

    Calculated as the mean pressure throughout the night.

    Time frame: 6-8 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07898254
Lead sponsor
NovaResp Technologies Inc
Responsible party
Sponsor
First posted
Oct 27, 2026
Start date
Nov 30, 2027 (estimated)
Primary completion
Nov 30, 2028 (estimated)
Completion
Nov 30, 2028 (estimated)
Last update
Oct 27, 2026

Study contacts

Megan Neil, BScN
Contact
megan.neil@novaresp.com
902-986-1660
Kaitlyn Dicks, BSc
Contact
kaitlyn@novarep.com
902-809-1543

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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