Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

NCT ID: NCT02470182

Last Updated: 2020-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 52 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2020-06-30

Brief Summary

The purpose of this study is to learn more about breathing disorders during sleep. The investigators want to learn how breathing sounds made during sleep relate to breathing disorders during sleep.

Detailed Description

The purpose of this study is to evaluate the feasibility of assessing breathing problems during sleep with minimally obtrusive sensors (a bedside microphone and wireless pulse oximeter worn on the fingertip). The investigators will use the data collected with these sensors to develop algorithms for automatically detecting sleep apnea events. Subjects will be asked to place unobtrusive sensors (bedside microphone and wireless pulse oximeter) in their home sleep environment. The subjects will start the at-home data collection before they fall asleep, and stop the data collection the next morning when they wake. The subjects will then return the sensors to the investigator for analysis.

We are looking for people interested in participating in the at-home portion of our study. We will only collect at-home data for one night of sleep per subject. After this one night, no further data collection or monitoring will occur. Subjects will be compensated for their time.

A standard sleep-breathing questionnaire (the "Berlin Questionnaire") will be administered. This questionnaire is widely used as a screening tool to determine if a person may have disordered breathing during sleep. This questionnaire consists of 10 multiple-choice questions related to snoring, daytime sleepiness, and other related conditions.

Conditions

Sleep Apnea Syndromes; Snoring

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

At-Home

Overnight sleep at home (30 subjects)

No interventions assigned to this group

Sleep Lab

Overnight sleep at the OHSU sleep lab during routine polysomnography (30 subjects)

No interventions assigned to this group

Sleep Lab + At-Home

Overnight sleep at the OHSU sleep lab during routine polysomnography, followed by overnight sleep at home (30 subjects)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 21-89
• No self-reported sleep breathing problems

Exclusion Criteria

• Prior diagnosis for a sleep breathing problem (such as sleep apnea)
• Self-reported insomnia
• History of stroke
• Nasal or soft palate surgery in the last 12 months
• Use of a breathing assistance device (such as a CPAP machine)

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Brian R Snider

Ph.D. Candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jan van Santen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Center for Spoken Language Understanding

Portland, Oregon, United States

Countries

United States

Other Identifiers

IRB00010124

Identifier Type: -

Identifier Source: org_study_id