Obstructive Sleep ApneaNCT06319482
The Adherence of Proactive Sleep Apnea Therapy
A study testing Proactive CPAP Therapy and Conventional APAP Therapy 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 compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Proactive CPAP Therapy and Conventional APAP Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteCanada
- Study dates
- 16 Jun 2024to 10 Apr 2026
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a new diagnosis of moderate or severe OSA (i.e., AHI > 15 events/hour).
- Must be 18-70 years old.
- No history of self-reported, uncontrolled, severe cardiovascular or neurological issues.
- Must be able to comply with all study requirements as outlined in the consent form.
- Must be able to follow the directions of the study doctor and research team.
- Must be able to understand English and be willing to provide informed consent.
Who cannot join
- Prior use of PAP machines.
- Subjects actively using bi-level PAP or require oxygen therapy.
- 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 to given 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.
- Pregnancy, planning to attempt to become pregnant, or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:
- To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients.
- To compare health outcomes (AHI, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.
Read the detailed description
This is a double-blind, randomized controlled superiority trial on newly diagnosed patients with obstructive sleep apnea. Each participant will be provided with a APAP device. The devices assigned to the test group will be modified to deliver the proactive therapy using Artificial Intelligence (AI). Devices assigned to the control group will deliver the conventional APAP therapy. A sleep technician will be in regular contact with participants and track the time spent interacting with each participant. At the conclusion of the first 3 months of the trial, participants who are acceptant to therapy will be asked if they would like to continue participating for an additional 9 months. Data will be collected by the PAP device and a series of self-reported questionnaires.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Proactive CPAP Therapy, Conventional APAP Therapy
- 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.
Proactive CPAP TherapyDevice
CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure.
Conventional APAP TherapyDevice
CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.
| Study group | Role | What they receive |
|---|---|---|
| Proactive CPAP Therapy (Intervention) | Experimental | Patients will undergo CPAP enabled with proactive therapy. Receives: Device: Proactive CPAP Therapy |
| Conventional APAP Therapy (Control) | Active comparator | Patients will undergo conventional APAP therapy. Receives: Device: Conventional APAP Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Calculated as at least 70% compliance (at least 4 hrs), in 30 days
Measured: 3-12 months
Secondary outcomes (4)
Apnea-Hypopnea Index
Calculated as the mean number of apnea and hypopnea events throughout the night in events/hr.
Measured: 3-12 months
CPAP Therapy Usage
Calculated as the mean device usage by the patient throughout the night.
Measured: 3-12 months
Self-assessed sleep outcomes
Patients will be requested to fill out a questionnaire to help evaluate their sleepiness before and after therapy.
Scale: Epworth Sleepiness Scale on a 7-point scale, higher values meaning worse outcome.
Measured: 3-12 months
Self-assessed functional outcomes
Patients will be requested to fill out a questionnaire to help evaluate their functional outcomes of sleep before and after therapy.
Scale: Functional Outcomes of Sleep Questionnaire on a 7-point scale, higher values meaning better outcomes.
Measured: 3-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start16 Jun 2024
- Primary completion10 Apr 2026
- Study completion10 Apr 2026
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaResp Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319482
- Sponsor's protocol ID
- Adherence Study
- Status last verified
- Oct 2024
- First submitted
- 6 Mar 2024
- 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
- Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
- ClinicalTrials.gov ID
- NCT06319482
- Acronym / sponsor ID
- Adherence Study
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- NovaResp Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2024 (actual)
- Primary completion
- 10 Apr 2026 (actual)
- Study completion
- 10 Apr 2026 (actual)
- First posted
- 20 Mar 2024 (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 the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are:
- To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients.
- To compare health outcomes (AHI, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.
Detailed description
This is a double-blind, randomized controlled superiority trial on newly diagnosed patients with obstructive sleep apnea. Each participant will be provided with a APAP device. The devices assigned to the test group will be modified to deliver the proactive therapy using Artificial Intelligence (AI). Devices assigned to the control group will deliver the conventional APAP therapy. A sleep technician will be in regular contact with participants and track the time spent interacting with each participant. At the conclusion of the first 3 months of the trial, participants who are acceptant to therapy will be asked if they would like to continue participating for an additional 9 months. Data will be collected by the PAP device and a series of self-reported questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proactive CPAP Therapy (Intervention) | Experimental | Device: Proactive CPAP TherapyPatients will undergo CPAP enabled with proactive therapy. |
| Conventional APAP Therapy (Control) | Active comparator | Device: Conventional APAP TherapyPatients will undergo conventional APAP 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 have a new diagnosis of moderate or severe OSA (i.e., AHI > 15 events/hour).
- Must be 18-70 years old.
- No history of self-reported, uncontrolled, severe cardiovascular or neurological issues.
- Must be able to comply with all study requirements as outlined in the consent form.
- Must be able to follow the directions of the study doctor and research team.
Key exclusion criteria (7 listed)
- Prior use of PAP machines.
- Subjects actively using bi-level PAP or require oxygen therapy.
- 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 to given written informed consent.
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 CPAP TherapyCPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure. | Device | Proactive CPAP Therapy (Intervention) |
| Conventional APAP TherapyCPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure. | Device | Conventional APAP Therapy (Control) |
Primary outcome
Adherence
Time frame: 3-12 months
Calculated as at least 70% compliance (at least 4 hrs), in 30 days
4 secondary outcomes
Apnea-Hypopnea Index
Time frame: 3-12 months
CPAP Therapy Usage
Time frame: 3-12 months
Self-assessed sleep outcomes
Time frame: 3-12 months
Self-assessed functional outcomes
Time frame: 3-12 months
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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 Proactive CPAP Therapy and Conventional APAP Therapy 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: finished, 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?
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?
Adherence (time frame: 3-12 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 16 Oct 2026.