Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)

Snoring Clinical Trial

Official title:

Validation of Downloadable Mobile Snore Applications by Polysomnography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03890549
• Other study ID #: 201801799B0
• Status: Not yet recruiting
• Start date: April 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: December 2018
• Source: Chang Gung Memorial Hospital
• Contact: YUAN-CHIEH YEH, Doctor
• Phone: 24313131
• Email: b9005030[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea, Obstructive
• Sleep Apnea, Obstructive
• Snoring

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Keelung Chang Gung Memorial Hospital	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	sleep time	total sleep time accessed by PSG and smart phone applications	through study completion during sleep, each sleep cycle about 6-8 hours