The Adherence of Proactive Sleep Apnea Therapy

NCT06319482 | Recruiting

• 1 other identifier: Adherence Study
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Adherence

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

  3-12 months

Secondary Outcomes (4)

• Apnea-Hypopnea Index

  3-12 months

• CPAP Therapy Usage

  3-12 months

• Self-assessed sleep outcomes

  3-12 months

• Self-assessed functional outcomes

  3-12 months

Study Arms (2)

Proactive CPAP Therapy (Intervention)

EXPERIMENTAL

Patients will undergo CPAP enabled with proactive therapy.

Device: Proactive CPAP Therapy

Conventional APAP Therapy (Control)

ACTIVE COMPARATOR

Patients will undergo conventional APAP therapy.

Device: Conventional APAP Therapy

Interventions

Proactive CPAP Therapy DEVICE

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

Proactive CPAP Therapy (Intervention)

Conventional APAP Therapy DEVICE

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

Conventional APAP Therapy (Control)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NovaResp Technologies Inc: lead

Study Sites (1)

NovaResp Technologies Inc.

Halifax, Nova Scotia, B3H 4H5, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Megan Neil, BScN

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 20, 2024
• Study Start: June 16, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: October 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)