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Sleep Apnea SyndromesNCT01680380

Tracking Breathing During Sleep With Non-contact Sensors

An observational study of Sleep Apnea Syndromes and Snoring, run by Oregon Health and Science University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to evaluate the feasibility of tracking breathing during sleep with non-contact sensors (for example, microphones or wireless movement sensors). The investigators will use the data collected with these sensors to develop algorithms for tracking breathing 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
0 participants
Where
1 siteUnited States
Study dates
Oct 2012to Aug 2016
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 will be recruited from the PI's department (OHSU faculty, Ph.D. students) by email and the investigators' personal acquaintances. Participants must be age 21-100 and have no self-reported sleep breathing problems.

Who may be able to join

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

Who cannot join

  • Positive diagnosis for sleep breathing problem (e.g., obstructive sleep apnea)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Center for Spoken Language Understanding

    Portland, Oregon, 97239

Other trials in United States

About this study

The purpose of this study is to evaluate the feasibility of tracking breathing during sleep with non-contact sensors (for example, microphones or wireless movement sensors). The investigators will use the data collected with these sensors to develop algorithms for tracking breathing during sleep. The investigators will assess the performance of the algorithms by comparing automatic output against manually-generated labels.

Read the detailed description

Subjects will be asked to place non-contact sensors (for example, ambient microphones, wireless movement sensors) in their home sleep environment. No sensors will be attached to or otherwise in contact with the subject's body. The subjects will start the 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.

The investigators will study the data and associated manual labeling. The investigators will develop algorithms that use statistical and machine-learning methods to train computer models designed to track breathing automatically. The investigators will compare the automatic output against manually generated labels to determine breath-tracking accuracy.

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 groups in NCT01680380
Study groupRoleWhat they receive
At-HomeOvernight sleep at home

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Breathing sounds are evident in overnight audio recordings

    This study aims to track breathing during sleep using a high-quality audio interface. Our primary objective is to determine if quiet breathing sounds are visible (in the spectral domain) to trained human labelers.

    Measured: Night of recording

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionAug 2016 (estimated)
  4. Study completionAug 2016 (estimated)

Why it stopped: Superseded by larger funded study

Resources

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01680380
Sponsor's protocol ID
IRB00008533
Status last verified
Jul 2016
First submitted
4 Sep 2012
Last updated
7 Jul 2016
Results posted
No
Data monitoring committee
No

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 1 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: withdrawn, as of the sponsor's last update on 7 Jul 2016. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Breathing sounds are evident in overnight audio recordings (time frame: Night of recording). 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 7 Jul 2016.

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