Obstructive Sleep ApneaNCT06144892
The Comfort of Proactive Sleep Apnea Therapy
A study testing Proactive Therapy in people with Obstructive Sleep Apnea and Sleep Apnea, run by NovaResp Technologies Inc at 1 site in Canada.
Trial summary
The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question[s] it aims to answer are: To assess if proactive therapy can effectively treat OSA with lower mean therapy pressure compared to conventional APAP therapy To compare user comfort between proactive… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep Apnea
- What is being tested?
- Proactive Therapy
- 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
- 25 Mar 2024to 30 Dec 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be a current CPAP user
- Must have used a PAP device for more than 4 months.
- Before the first night of the study, participant must be willing to lend their personal PAP device for inspection in order for the study coordinator to transfer their PAP therapy settings to one of our modified PAP devices.
- Must be willing to wear the sleep diagnostic ring throughout each night of the study for the entire study duration (i.e., the full 23 days).
- Must be willing to have their CPAP SD memory card analyzed to determine their mean pressure and excess leak rate history
- Must be free of flu-like illness or any upper tract infection symptoms at the time of data collection.
Who cannot join
- Subjects actively using bi-level PAP or require oxygen therapy.
- Inspection of the participant's CPAP SD card data shows that history of highly frequent excess leak during therapy. Exclusion due to high leak will be determined on a case-by-case basis.
- History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months.
- Subjects who are medically complicated or who are medically unstable (i.e., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness)
- Potential sleep apnea complications that in the opinion of the clinician may affect the health and safety of the participant.
- Inability or unwillingness of individual to give written informed consent.
- 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 (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Comfort and Effectiveness of Proactive Airway Management Therapy for Sleep Apnea
The goal of this clinical trial is to compare in OSA patients who regularly adhere to CPAP therapy. The main question[s] it aims to answer are:
- To assess if proactive therapy can effectively treat OSA with lower mean therapy pressure compared to conventional APAP therapy
- To compare user comfort between proactive therapy and conventional APAP therapy
Participants will undergo the conventional APAP therapy and the new proactive therapy.
Researchers will compare nights in which conventional APAP was used and nights in which proactive therapy was used to see if patients were treated with lower pressures and effectively.
Read the detailed description
This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each participant. Participants will use a modified APAP device for 2 periods of 9 nights each, separated by 5 nights in which participants will use their personal APAP device. The modified APAP device is switchable between two therapy modes: a) proactive therapy, and b) conventional APAP therapy. Treatment for the 2 periods will be randomly assigned, with one period as the test period where the proactive therapy is used every night for 9 consecutive nights, and the other as the control period where their conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) is used every night for 9 consecutive nights. Participants will be blinded to the therapy they are receiving during the test and control period. Data will be collected by the modified PAP device and at-home sleep apnea test ring.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Being tested
- Proactive Therapy
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive TherapyDevice
Uses AI to make predictions and preventions of future apneic events.
| Study group | Role | What they receive |
|---|---|---|
| Intervention first | Experimental | Patients will undergo proactive therapy first, followed by the buffer period, and finally the conventional APAP therapy. Receives: Device: Proactive Therapy |
| Control first | Experimental | Patients will undergo the conventional APAP therapy first, followed by the buffer period, and finally the proactive therapy. Receives: Device: Proactive Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mask pressure
Calculated as the mean pressure throughout the night.
Measured: 18 nights
Secondary outcomes (3)
Apnea-Hypopnea Index
Calculated as the mean number of apnea and hypopnea events throughout the night, in events/hr.
Measured: 18 nights
Comfort score
Questionnaire that measures comfort of therapy.
Measured: 18 nights
Sleepiness self-assessment
Patients will be requested to fill out a questionnaire to help evaluate their sleepiness after the treatment period and control period
Measured: 18 nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start25 Mar 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- 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
- NCT06144892
- Sponsor's protocol ID
- comfort study
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2023
- Last updated
- 16 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Comfort and Effectiveness of Proactive Airway Management Therapy for Sleep Apnea
- ClinicalTrials.gov ID
- NCT06144892
- Acronym / sponsor ID
- comfort study
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NovaResp Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 22 Nov 2023 (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 compare in OSA patients who regularly adhere to CPAP therapy. The main question[s] it aims to answer are:
- To assess if proactive therapy can effectively treat OSA with lower mean therapy pressure compared to conventional APAP therapy
- To compare user comfort between proactive therapy and conventional APAP therapy
Participants will undergo the conventional APAP therapy and the new proactive therapy.
Researchers will compare nights in which conventional APAP was used and nights in which proactive therapy was used to see if patients were treated with lower pressures and effectively.
Detailed description
This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each participant. Participants will use a modified APAP device for 2 periods of 9 nights each, separated by 5 nights in which participants will use their personal APAP device. The modified APAP device is switchable between two therapy modes: a) proactive therapy, and b) conventional APAP therapy. Treatment for the 2 periods will be randomly assigned, with one period as the test period where the proactive therapy is used every night for 9 consecutive nights, and the other as the control period where their conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) is used every night for 9 consecutive nights. Participants will be blinded to the therapy they are receiving during the test and control period. Data will be collected by the modified PAP device and at-home sleep apnea test ring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention first | Experimental | Device: Proactive TherapyPatients will undergo proactive therapy first, followed by the buffer period, and finally the conventional APAP therapy. |
| Control first | Experimental | Device: Proactive TherapyPatients will undergo the conventional APAP therapy first, followed by the buffer period, and finally the proactive therapy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Must be a current CPAP user
- Must have used a PAP device for more than 4 months.
- Before the first night of the study, participant must be willing to lend their personal PAP device for inspection in order for the study coordinator to transfer their PAP therapy settings to one of our modified PAP devices.
- Must be willing to wear the sleep diagnostic ring throughout each night of the study for the entire study duration (i.e., the full 23 days).
- Must be willing to have their CPAP SD memory card analyzed to determine their mean pressure and excess leak rate history
Key exclusion criteria (7 listed)
- Subjects actively using bi-level PAP or require oxygen therapy.
- Inspection of the participant's CPAP SD card data shows that history of highly frequent excess leak during therapy. Exclusion due to high leak will be determined on a case-by-case basis.
- History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months.
- Subjects who are medically complicated or who are medically unstable (i.e., cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness)
- Potential sleep apnea complications that in the opinion of the clinician may affect the health and safety of the participant.
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 |
|---|---|---|
| Proactive TherapyUses AI to make predictions and preventions of future apneic events. | Device | Control first, Intervention first |
Primary outcome
Mask pressure
Time frame: 18 nights
Calculated as the mean pressure throughout the night.
3 secondary outcomes
Apnea-Hypopnea Index
Time frame: 18 nights
Comfort score
Time frame: 18 nights
Sleepiness self-assessment
Time frame: 18 nights
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 16 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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 Proactive Therapy in people with Obstructive Sleep Apnea and 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: under way, not looking for participants, as of the sponsor's last update on 16 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?
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?
Mask pressure (time frame: 18 nights). 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 16 Oct 2026.