Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)
1 other identifier
observational
100
1 country
1
Brief Summary
The aim of this study is to validate the downloadable mobile snore applications by polysomnography.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
April 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedMarch 26, 2019
December 1, 2018
1.4 years
March 20, 2019
March 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
obstructive sleep apnea group
The patients were diagnosed by thoracic and ENT (Eye-Nose-Throat) specialist through polysomnography.
Interventions
The investigators selected 3 appropriate downloadable smart phone applications for snoring recording and make validation with the golden standard of polysomnography.
Eligibility Criteria
All patients diagnosed as obstructive sleep apnea no matter disease severity.
You may qualify if:
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI (apnea-hypopnea index) \< 30
You may not qualify if:
- Significant lung disease
- Skeletal facial framework problems
- Central apnea
- Receiving acupuncture in recent 2 weeks
- Taking hypnotic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Keelung Chang Gung Memorial Hospital
Keelung, 20401, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2019
First Posted
March 26, 2019
Study Start
April 1, 2019
Primary Completion
August 31, 2020
Study Completion
December 1, 2020
Last Updated
March 26, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share
1. There will be a research number representing the identity. This number will not display the name, identification number, and address. 2. 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. 3. 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.