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Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470182
Recruitment Status : Active, not recruiting
First Posted : June 12, 2015
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
Brian R Snider, Oregon Health and Science University

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.

Condition or disease
Sleep Apnea Syndromes Snoring

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.

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Study Type : Observational
Actual Enrollment : 52 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
Study Start Date : September 2014
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

Group/Cohort
At-Home
Overnight sleep at home (30 subjects)
Sleep Lab
Overnight sleep at the OHSU sleep lab during routine polysomnography (30 subjects)
Sleep Lab + At-Home
Overnight sleep at the OHSU sleep lab during routine polysomnography, followed by overnight sleep at home (30 subjects)



Primary Outcome Measures :
  1. Non-typical breathing sounds or patterns correspond to oxygen desaturation [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470182


Locations
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United States, Oregon
Center for Spoken Language Understanding
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Jan van Santen, Ph.D. Oregon Health and Science University
Additional Information:
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Responsible Party: Brian R Snider, Ph.D. Candidate, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02470182    
Other Study ID Numbers: IRB00010124
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Keywords provided by Brian R Snider, Oregon Health and Science University:
sleep apnea
snoring
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Snoring
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms