Screening for Sleep Disordered Breathing With Minimally O... | NCT02470182

Studies
Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

NCT02470182

Sponsor

Oregon Health and Science University

Status

Unknown status

Last Update Posted

Jan 9, 2020Actual

Enrollment

52Actual

Phase

Not provided

Conditions

Sleep Apnea Syndromes
Snoring

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Oct 2016Actual

Completion Date

Jun 2020Estimated

First Submitted Date

May 26, 2015

First Submission Date that Met QC Criteria

Jun 9, 2015

First Posted Date

Jun 12, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2020

Last Update Posted Date

Jan 9, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Brian R Snider, Ph.D. Candidate, Oregon Health and Science UniversityPrincipal Investigator

Lead Sponsor

Oregon Health and Science UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan van Santen, Ph.D.	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center for Spoken Language Understanding		Portland	Oregon	97239	United States

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D012913	Snoring

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided