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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

272 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-02-13

Study Completion Date

2017-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comprehensive Analysis of Respiratory Events Using Smartphone Systems

NCT03457428

Obstructive Sleep Apnea

TERMINATED

Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study

NCT02952118

Snoring

UNKNOWN NA

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

NCT02034175

Obstructive Sleep Apnea Central Sleep Apnea Mixed Sleep Apnea +1 more

COMPLETED NA

Validation of a Snoring App Against Commercially Available Applications and PSG

NCT07097597

Snoring Obstructive Sleep Apnea (OSA)

NOT_YET_RECRUITING

Evaluating Accuracy of Breath Sound Recordings and STOP-Bang Screening For Obstructive Sleep Apnea While Awake

NCT02987283

Sleep Apnea, Obstructive

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes