Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02470182

Enrollment

Registered

2015-06-12

Start date

2014-09-30

Completion date

2020-06-30

Last updated

2020-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes, Snoring

Keywords

sleep apnea, snoring

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

21 Years to 89 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Non-typical breathing sounds or patterns correspond to oxygen desaturation	On the day of the study only (1 day)	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.

Countries

United States

Outcome results