Sleep Apnea SyndromesNCT02470182
Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
An observational study of Sleep Apnea Syndromes and Snoring, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes, Snoring
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Age 21-89
- No self-reported sleep breathing problems
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Spoken Language Understanding
Portland, Oregon, 97239
About this study
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.
Read the 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.
- Conditions
- Sleep Apnea Syndromes, Snoring
- Keywords
- sleep apnea, snoring
- Medical subject headings
- Sleep Apnea Syndromes, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of the study only (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionOct 2016
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian R Snider, Oregon Health and Science University
- Investigators
- Jan van Santen, Ph.D., Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02470182
- Sponsor's protocol ID
- IRB00010124
- Status last verified
- Jan 2020
- First submitted
- 26 May 2015
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors
- ClinicalTrials.gov ID
- NCT02470182
- Acronym / sponsor ID
- IRB00010124
- Conditions
- Sleep Apnea Syndromes, Snoring
- Keywords
- sleep apnea, snoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 12 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (2 listed)
- Age 21-89
- No self-reported sleep breathing problems
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan van Santen, Ph.D. principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea Syndromes and Snoring, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-typical breathing sounds or patterns correspond to oxygen desaturation (time frame: On the day of the study only (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.