Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)

Validation of Downloadable Mobile Snore Applications by Polysomnography

The aim of this study is to validate the downloadable mobile snore applications by polysomnography.

Study Overview

• Status: Unknown
• Conditions: Snoring; Apnea, Obstructive
• Intervention / Treatment: Diagnostic test: SnoreLab (smart phone application for snoring recording)

Detailed Description

Obstructive sleep apnea(OSA) is characterized by multiple episodes of upper airway collapse during sleep and considered as a major health issue worldwide due to comorbidity with obesity, hypertension, diabetes and more advanced cardiovascular diseases. The noisy sounds of snoring caused by OSA bother bed partner sleepless and lead to long-term health problems. Mobile snore applications are convenient and accessible for patients to monitor the progress of OSA by themselves, but there are no reliable PSG-validated applications.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: YUAN-CHIEH YEH, Doctor; Phone Number: 2127 24313131; Email: b9005030@gmail.com
• Study Contact Backup: Name: YI-HSIEN SHIAO, Doctor; Phone Number: 2127 24313131; Email: vincentking44@gmail.com

Study Locations

• Taiwan
  • Keelung, Taiwan, 20401
    • Keelung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients diagnosed as obstructive sleep apnea no matter disease severity.

Description

Inclusion Criteria:

• Willing to sign inform consent with aged more than 20 years old
• Mild to moderate OSA, AHI (apnea-hypopnea index) < 30

Exclusion Criteria:

• Significant lung disease
• Skeletal facial framework problems
• Central apnea
• Receiving acupuncture in recent 2 weeks
• Taking hypnotic drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
obstructive sleep apnea group; The patients were diagnosed by thoracic and ENT (Eye-Nose-Throat) specialist through polysomnography.	Diagnostic test: SnoreLab (smart phone application for snoring recording); The investigators selected 3 appropriate downloadable smart phone applications for snoring recording and make validation with the golden standard of polysomnography.; Other Names: Sleep Cycle alarm clock (smart phone application for snoring recording); Anti Snore Solution (smart phone application for snoring recording)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
snore time	snoring time during sleep accessed by PSG and smart phone applications	through study completion during sleep, each sleep cycle about 6-8 hours
snore counts	snoring counts during sleep accessed by PSG and smart phone applications	through study completion during sleep, each sleep cycle about 6-8 hours
snore sound	snoring sound during sleep accessed by PSG and smart phone applications	through study completion during sleep, each sleep cycle about 6-8 hours
sleep time	total sleep time accessed by PSG and smart phone applications	through study completion during sleep, each sleep cycle about 6-8 hours

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 20, 2019
• First Submitted That Met QC Criteria: March 24, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 24, 2019
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: polysomnography; obstructive sleep apnea; smart phone application
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Sounds; Sleep Apnea, Obstructive; Snoring
• Other Study ID Numbers: 201801799B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There will be a research number representing the identity. This number will not display the name, identification number, and address.; For the results and diagnosis of the visit, the research host will maintain a confidential attitude and carefully maintain the privacy. If research results are published, the identity will remain confidential.; Please also understand that if the participant signs the consent form, the participant agrees that the visit record can be directly reviewed by the monitor, auditor, research ethics committee and the competent authority to ensure that the research process and data comply with relevant laws and regulations. These people also promise not to violate the confidentiality of your identity.

Drug and device information, study documents

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