The Comfort of Proactive Sleep Apnea Therapy

NCT06144892 | Not Yet Recruiting

• 1 other identifier: comfort study
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Mask pressure

  Calculated as the mean pressure throughout the night.

  18 nights

Secondary Outcomes (3)

• Apnea-Hypopnea Index

  18 nights

• Comfort score

  18 nights

• Sleepiness self-assessment

  18 nights

Study Arms (2)

Intervention first

EXPERIMENTAL

Patients will undergo proactive therapy first, followed by the buffer period, and finally the conventional APAP therapy.

Device: Proactive Therapy

Control first

EXPERIMENTAL

Patients will undergo the conventional APAP therapy first, followed by the buffer period, and finally the proactive therapy.

Device: Proactive Therapy

Interventions

Proactive Therapy DEVICE

Uses AI to make predictions and preventions of future apneic events.

Control first; Intervention first

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 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.

You may not qualify if:

• Subjects actively using bi-level PAP or require oxygen therapy.
• 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.

Sponsors & Collaborators

• NovaResp Technologies Inc: lead

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 22, 2023
• Study Start: March 25, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share