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Sleep Apnea, ObstructiveSNORESOUNDSNCT03288376

SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS

An observational study of Sleep Apnea, Obstructive and Chronic Obstructive Pulmonary Disease, run by Incyphae, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective multipart clinical performance study to compare the ability of the SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST) device to identify patients with obstructive sleep apnea (OSA). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
272 participants
Where
3 sitesUnited States
Study dates
13 Feb 2015to 31 Jan 2017
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Men and women aged >or= 18 years who are referred for polysomnography (PSG) or Home Sleep Test (HST) because of possible obstructive sleep apnea (OSA).

Who may be able to join

  • Patients >or= 18 years old who are referred for polysomnography (PSG) or Home Sleep Test (HST) because of possible obstructive sleep apnea (OSA)

Who cannot join

  • Previous PSG or HST confirming OSA
  • Prior surgery for snoring or OSA
  • Medical contraindication for PSG
  • Cognitive impairment that might interfere with obtaining informed consent or completing Clinical Questionnaire

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Peninsula Sleep Center

    Burlingame, California, 94010

  • Doctors Community Hospital

    Lanham, Maryland, 20706

  • Northeast Medical Group

    New London, Connecticut, 06320

Other trials in United States

About this study

This is a prospective multipart clinical performance study to compare the ability of the SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST) device to identify patients with obstructive sleep apnea (OSA).

Read the detailed description

Consecutive patients referred to a sleep lab for possible OSA (obstructive sleep apnea) will be offered participation in this study. Study subjects will participate in either Part A, Part B or Part C of the study. Subjects will not participate in more than one part of the study. Study sites can participate in multiple parts of the study.

Part A: Sleep Lab

Consecutive patients referred to a sleep lab for possible OSA will be offered participation. Participants who provide informed consent will fill out a questionnaire and then have PSG, as it would normally be performed. During PSG additional sound recordings will be made in three ways:

  1. Microphone placed 50-100 cm (20-40 inches) from the patient's mouth.
  2. Android type Smart Phone with a recording application (app). The phone will be placed on a table 50-100 cm (20-40 inches)) from patient's mouth.
  3. iPhone type Smart Phone with a recording app. Phone will be placed on a table 50-100 cm (20-40 inches) from patient's mouth.

The sound recordings obtained via the microphone and Smart Phones will be analyzed electronically for OSA by the sponsor's proprietary algorithm. A blinded comparison will be made between the PSG results and SnoreSounds algorithm results.

PSG will be performed and scored in a manner consistent with current (2012) American Academy of Sleep Medicine (AASM) standards. PSGs will be scored twice - with each scoring performed independently. If the Apnea Hypopnea Index (AHI) for each score places the patient in the same OSA severity range [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe] the average of the two scores will be utilized. If however the scores put the patent in different OSA severity ranges, then the study will be scored by an independent sleep medicine physician-sleep technician team and assigned an AHI.

The results of the SnoreSounds testing will not be known to the sleep lab and the results obtained from Snore Sounds analysis will not be utilized in the clinical management of study participants.

Part B: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) (currently not enrolling in Part B)

Part C: Comparison of SnoreSounds algorithm to Home Sleep Testing (HST) and to Polysomnography (PSG) (currently not enrolling in Part C)

Keywords
obstructive sleep apnea, polysomnography
Medical subject headings
Sleep Apnea, Obstructive, Pulmonary Disease, Chronic Obstructive

What is being measured

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

  1. Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15

    Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15

    Measured: immediate

Secondary outcomes (1)

  1. Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe].

    Comparison between algorithm and PSG assignment of OSA severity based on AHI [0-4 normal/minimal OSA, 5-14 mild, 15-30 moderate, >30 severe].

    Measured: immediate

Timeline

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

  1. First posted20 Sep 2017
  2. Study start13 Feb 2015
  3. Primary completion31 Jan 2017
  4. Study completion31 Jan 2017

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
Prospective
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03288376
Sponsor's protocol ID
SNORE_SOUNDS
Acronym
SNORESOUNDS
Status last verified
Aug 2019
First submitted
13 Sep 2017
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pandian TNG, Sehra R, Narayan S. Breath variability increases in the minutes preceding obstructive sleep apneic events. Sleep Breath. 2021 Mar;25(1):271-280. doi: 10.1007/s11325-020-02094-1. Epub 2020 Jun 6.

    PubMed 32506203

  • Narayan S, Shivdare P, Niranjan T, Williams K, Freudman J, Sehra R. Noncontact identification of sleep-disturbed breathing from smartphone-recorded sounds validated by polysomnography. Sleep Breath. 2019 Mar;23(1):269-279. doi: 10.1007/s11325-018-1695-6. Epub 2018 Jul 18.

    PubMed 30022325

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Apnea, Obstructive and Chronic Obstructive Pulmonary Disease, run by Incyphae, Inc. at 3 sites 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Agreement between algorithm with PSG reference standard for detection of OSA at an AHI cut-off of 15 (time frame: immediate). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03288376, which also lists 2 linked publications.

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 Aug 2019.

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