Acoustic OSA Prediction During Wakefulness and Monitoring During Sleep

NCT04112927 | Active Not Recruiting

• 1 other identifier: B2018:094
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the feasibility of sound analysis for: a) sleep apnea detection both during wakefulness and sleep, and b) flow-sound relationship during both wakefulness and sleep in patients and control individuals. The ultimate goal of our research is to simplify the current assessments for sleep apnea detection so that it is more convenient for patients and also much faster than the current techniques.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; OSA; Respiratory Sound Analysis; AwakeOSA

Outcome Measures

Primary Outcomes (1)

• OSA Severity

  Data recorded during wakefulness will be analyzed using our published AWakeOSA algorithm to classify the participants into two groups of those who have AHI below and above 15. We will also run Multivariate statistical analysis to find the main effect of OSA severity (AHI) on the sound features and their interaction with the anthropometric information.

  1 Day

Secondary Outcomes (1)

• Acoustic AHI correlation to PSG

  1 Day

Study Arms (2)

OSA Participants

Inclusion Criteria: 1) age between 18 to 70 years; 2) suspected of OSA and referred to full PSG study by a doctor. Exclusion Criteria: 1) being diagnosed with a chronic respiratory disease including pulmonary fibrosis, emphysema, respiratory infectious disease, nocturnal asthma, obstructive pulmonary lung disease, pulmonary hypertension, congestive heart failure, sleep related hypoventilation and neuromuscular disorders; 2) having insomnia or restless leg; 3) drug addiction; and 4) under the current, direct supervision of the PI of this study.

Healthy Controls

Inclusion Criteria: 1) age between 18 to 70 years; 2) non-snorer, and being free of any sleep disorders. Exclusion Criteria: same as the OSA Participants. All participants must not have any cold or any other respiratory illness at the time of recording. Illiterate participants may still participate in the study; however, there must be a witness who is not involved in the study (i.e. PI, Co-PI, study coordinator, research assistants (RA)/students, etc.) present to witness the consent process between the participant and the individual obtaining consent.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OSA Participants of this study will be anyone regardless of their sex, gender or ethnic background, who are suspected of OSA and meet the inclusion/exclusion criteria. In addition, we will record up to 50 healthy controls.

You may qualify if:

• \) age between 18 to 70 years.
• \) suspected of OSA and referred to full PSG study by a doctor.

You may not qualify if:

• \) being diagnosed with a chronic respiratory disease including pulmonary fibrosis, emphysema, respiratory infectious disease, nocturnal asthma, obstructive pulmonary lung disease, pulmonary hypertension, congestive heart failure, sleep related hypoventilation and neuromuscular disorders.
• \) having insomnia or restless leg.
• \) drug addiction.
• \) under the current, direct supervision of the PI of this study.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3t5V6, Canada

Location

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

Study Officials

• Zahra Kazem-Moussavi, Ph.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: October 1, 2021
• Primary Completion: December 1, 2023
• Study Completion (Estimated): December 23, 2026
• Last Updated: April 3, 2025

Record last verified: 2024-08

Locations

CA (1)