Recruiting

Observational Study

Sponsor:

NovaResp Technologies Inc

Code:

NCT06319482

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Proactive CPAP Therapy

Conventional APAP Therapy

Study Details

Brief 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. 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.
2. To compare health outcomes (AHI, nightly usage, leak, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.

Conditions

Obstructive Sleep Apnea

Study ID

NCT06319482

Start date

Jun 16, 2024

Status verified date

Oct, 2024

Completion date

Jun 16, 2025

Anticipated

Primary completion date

Jun 16, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Proactive CPAP Therapy (Intervention)

Patients will undergo CPAP enabled with proactive therapy.

active comparator: Conventional APAP Therapy (Control)

Patients will undergo conventional APAP therapy.

Interventions

Proactive CPAP Therapy

CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure.

Conventional APAP Therapy

CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.

Primary outcome measure

  • Adherence [ Time Frame: 3-12 months ]

Central Contacts and Locations

Central contacts

Megan Neil, BScN

902-986-1660megan.neil@novaresp.com

Locations

NovaResp Technologies Inc.

Recruiting

Halifax, Nova Scotia, Canada, B3H 4H5

Contacts

Rachelle Lalande, BSc

902-293-8783lalande@novaresp.com

More Information

Sponsor

NovaResp Technologies Inc

Last update posted

Oct 4, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NovaResp Technologies Inc on 2024-10-04.