The Adherence of Proactive Sleep Apnea Therapy

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319482
• Other study ID #: Adherence Study
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: March 2024
• Source: NovaResp Technologies Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 pressure, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NovaResp Technologies Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence	Calculated as hours of PAP device use nightly.	3-12 months
Secondary	Apnea-Hypopnea Index	Calculated as the mean number of apnea and hypopnea events throughout the night in events/hr.	3-12 months
Secondary	CPAP Pressure	Calculated as the mean pressure delivered by the CPAP throughout the night.	3-12 months
Secondary	Self-assessed sleep outcomes	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.	3-12 months
Secondary	Self-assessed functional outcomes	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.	3-12 months