NovaResp Technologies Inc.
Halifax, Nova Scotia, B3H 4H5, Canada
Location status: Recruiting
NCT Number: NCT06319482
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Halifax, Nova Scotia, B3H 4H5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CPAP machine uses Artificial Intelligence to make predictions and preventions of future apneic events to auto-adjust pressure.
CPAP machine relies on the detection of respiratory events to determine how to react and auto-adjust pressure.
Time frame: 3-12 months
Calculated as at least 70% compliance (at least 4 hrs), in 30 days
Time frame: 3-12 months
Calculated as the mean number of apnea and hypopnea events throughout the night in events/hr.
Time frame: 3-12 months
Calculated as the mean device usage by the patient throughout the night.
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.
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.
Contact information is provided by the study sponsor or research team.
NovaResp Technologies Inc
Industry
Evaluating and Comparing the Adherence of Proactive Management Therapy for Sleep Apnea
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.
Published trials that share one or more normalized conditions with this study.
NCT07273019
Apnea, Dyssomnias
Bron, France
View Trial DetailsNCT07723144
Apnea, Dyssomnias
Bialystok, Podlaskie Voivodeship, Poland
View Trial DetailsNCT06390345
Apnea, Body Weight
Boise, Idaho, United States
View Trial DetailsNCT05293600
Apnea, Dyssomnias
Boston, Massachusetts, United States
View Trial Details