Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

Sleep Apnea Syndromes Clinical Trial

Official title:

Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02470182
• Other study ID #: IRB00010124
• Status: Active, not recruiting
• Start date: September 2014
• Est. completion date: June 2020

Study information

• Verified date: January 2020
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: June 2020
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Snoring

Locations

Country	Name	City	State
United States	Center for Spoken Language Understanding	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-typical breathing sounds or patterns correspond to oxygen desaturation	This study aims to see if it is feasible to assess breathing problems during sleep using a high-quality microphone and wireless pulse oximeter. Our primary objective is to determine if non-typical breathing sounds or patterns correspond to oxygen desaturations of 3% or more from baseline.	On the day of the study only (1 day)

External Links

•   NIH RePORTER Listing