The Comfort of Proactive Sleep Apnea Therapy

Comparing the Comfort and Effectiveness of Proactive Airway Management Therapy for Sleep Apnea

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea; Sleep Apnea
• Intervention / Treatment: Device: Proactive Therapy

Detailed Description

This is a blinded, randomised, crossover, study on patients diagnosed with obstructive sleep apnea who regularly adhere to APAP therapy. Data collection will span 23 consecutive nights for each participant. Participants will use a modified APAP device for 2 periods of 9 nights each, separated by 5 nights in which participants will use their personal APAP device. The modified APAP device is switchable between two therapy modes: a) proactive therapy, and b) conventional APAP therapy. Treatment for the 2 periods will be randomly assigned, with one period as the test period where the proactive therapy is used every night for 9 consecutive nights, and the other as the control period where their conventional APAP therapy (i.e., the participant's regular therapy but on the modified device) is used every night for 9 consecutive nights. Participants will be blinded to the therapy they are receiving during the test and control period. Data will be collected by the modified PAP device and at-home sleep apnea test ring.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects actively using bi-level PAP or require oxygen therapy.
• Inspection of the participant's CPAP SD card data shows that history of highly frequent excess leak during therapy. Exclusion due to high leak will be determined on a case-by-case basis.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention first; Patients will undergo proactive therapy first, followed by the buffer period, and finally the conventional APAP therapy.	Device: Proactive Therapy; Uses AI to make predictions and preventions of future apneic events.
Experimental: Control first; Patients will undergo the conventional APAP therapy first, followed by the buffer period, and finally the proactive therapy.	Device: Proactive Therapy; Uses AI to make predictions and preventions of future apneic events.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mask pressure	Calculated as the mean pressure throughout the night.	18 nights

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea-Hypopnea Index	Calculated as the mean number of apnea and hypopnea events throughout the night, in events/hr.	18 nights
Comfort score	Questionnaire that measures comfort of therapy.	18 nights
Sleepiness self-assessment	Patients will be requested to fill out a questionnaire to help evaluate their sleepiness after the treatment period and control period	18 nights

Collaborators and Investigators

• Sponsor: NovaResp Technologies Inc

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2024
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: November 17, 2023
• First Posted (Actual): November 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: comfort study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No