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

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).

Study Overview

• Status: Completed
• Conditions: Sleep Apnea, Obstructive; Chronic Obstructive Pulmonary Disease

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)

• Study Type: Observational
• Enrollment (Actual): 272

Contacts and Locations

Study Locations

• United States
  • California
    • Burlingame, California, United States, 94010
      • Peninsula Sleep Center
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Northeast Medical Group
  • Maryland
    • Lanham, Maryland, United States, 20706
      • Doctors Community Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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).

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	immediate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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].	immediate

Collaborators and Investigators

• Sponsor: Incyphae, Inc.
• Investigators: Principal Investigator: Ruchir Sehra, MD, Incyphae, Inc.

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2015
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): January 31, 2017

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 14, 2017
• First Posted (Actual): September 20, 2017

Study Record Updates

• Last Update Posted (Actual): August 7, 2019
• Last Update Submitted That Met QC Criteria: August 5, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: polysomnography; obstructive sleep apnea
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: SNORE_SOUNDS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No