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NCT Number: NCT06319482

The Adherence of Proactive Sleep Apnea Therapy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NovaResp Technologies Inc.

Halifax, Nova Scotia, B3H 4H5, Canada

Location status: Recruiting

Location contact

Rachelle Lalande, BSc

CONTACT

[email protected]

902-293-8783

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Proactive CPAP Therapy

Device

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

Conventional APAP Therapy

Device

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

Primary outcomes

  1. Adherence

    Time frame: 3-12 months

    Calculated as at least 70% compliance (at least 4 hrs), in 30 days

Secondary outcomes

  1. Apnea-Hypopnea Index

    Time frame: 3-12 months

    Calculated as the mean number of apnea and hypopnea events throughout the night in events/hr.

  2. CPAP Therapy Usage

    Time frame: 3-12 months

    Calculated as the mean device usage by the patient throughout the night.

  3. Self-assessed sleep outcomes

    Time frame: 3-12 months

    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.

  4. Self-assessed functional outcomes

    Time frame: 3-12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Megan Neil, BScN

CONTACT

[email protected]

902-986-1660

Sponsors and collaborators

Lead sponsor

NovaResp Technologies Inc

Industry

Registry information

Official study title

Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 20, 2024
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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