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Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)

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ClinicalTrials.gov Identifier: NCT03890549
Recruitment Status : Unknown
Verified December 2018 by Chang Gung Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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Brief Summary:
The aim of this study is to validate the downloadable mobile snore applications by polysomnography.

Condition or disease Intervention/treatment
Apnea, Obstructive Snoring 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Validation of Downloadable Mobile Snore Applications by Polysomnography
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. snore time [ Time Frame: through study completion during sleep, each sleep cycle about 6-8 hours ]
    snoring time during sleep accessed by PSG and smart phone applications

  2. snore counts [ Time Frame: through study completion during sleep, each sleep cycle about 6-8 hours ]
    snoring counts during sleep accessed by PSG and smart phone applications

  3. snore sound [ Time Frame: through study completion during sleep, each sleep cycle about 6-8 hours ]
    snoring sound during sleep accessed by PSG and smart phone applications

  4. sleep time [ Time Frame: through study completion during sleep, each sleep cycle about 6-8 hours ]
    total sleep time accessed by PSG and smart phone applications


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients diagnosed as obstructive sleep apnea no matter disease severity.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890549


Contacts
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Contact: YUAN-CHIEH YEH, Doctor 24313131 ext 2127 b9005030@gmail.com
Contact: YI-HSIEN SHIAO, Doctor 24313131 ext 2127 vincentking44@gmail.com

Locations
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Taiwan
Keelung Chang Gung Memorial Hospital
Keelung, Taiwan, 20401
Sponsors and Collaborators
Chang Gung Memorial Hospital
More Information
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03890549    
Other Study ID Numbers: 201801799B0
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:
  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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
obstructive sleep apnea
polysomnography
smart phone application
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Snoring
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Respiratory Sounds
Signs and Symptoms, Respiratory