Clinical trial NCT02470182: Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
Official title: Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Apnea Syndromes
Snoring
Keywords: sleep apnea
snoring
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2015-06-12
Enrollment: 52
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants must be age 21-89 and have no self-reported sleep breathing problems. Participants must not use a breathing assistance device (such as a continuous positive airway pressure, or CPAP, machine) during sleep.

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.

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)

Primary outcomes:
measure: Non-typical breathing sounds or patterns correspond to oxygen desaturation
timeFrame: On the day of the study only (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Center for Spoken Language Understanding
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jan van Santen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: