NCT02470182

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 12, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

May 26, 2015

Last Update Submit

January 7, 2020

Conditions

Keywords

sleep apneasnoring

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (3)

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)

Eligibility Criteria

Age21 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Spoken Language Understanding

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSnoring

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jan van Santen, Ph.D.

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Candidate

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 12, 2015

Study Start

September 1, 2014

Primary Completion

October 1, 2016

Study Completion

June 1, 2020

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations