Apnea, ObstructiveNCT03890549
Validation of Downloadable Mobile Snore Applications by Polysomnography (PSG)
An observational study of Apnea, Obstructive and Snoring, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The aim of this study is to validate the downloadable mobile snore applications by polysomnography. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Apnea, Obstructive, Snoring
- What is being tested?
- SnoreLab (smart phone application for snoring recording)
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients diagnosed as obstructive sleep apnea no matter disease severity.
Who may be able to join
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI (apnea-hypopnea index) < 30
Who cannot join
- Significant lung disease
- Skeletal facial framework problems
- Central apnea
- Receiving acupuncture in recent 2 weeks
- Taking hypnotic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of Downloadable Mobile Snore Applications by Polysomnography
The aim of this study is to validate the downloadable mobile snore applications by polysomnography.
Read the 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.
- Conditions
- Apnea, Obstructive, Snoring
- Being tested
- SnoreLab (smart phone application for snoring recording)
- Keywords
- obstructive sleep apnea, polysomnography, smart phone application
- Medical subject headings
- Sleep Apnea, Obstructive, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SnoreLab (smart phone application for snoring recording)Diagnostic test
Also called Sleep Cycle alarm clock (smart phone application for snoring recording), Anti Snore Solution (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.
| Study group | Role | What they receive |
|---|---|---|
| obstructive sleep apnea group | The patients were diagnosed by thoracic and ENT (Eye-Nose-Throat) specialist through polysomnography. Receives: Diagnostic Test: SnoreLab (smart phone application for snoring recording) |
What is being measured
The primary outcome is the main question the study is designed to answer.
snore time
snoring time during sleep accessed by PSG and smart phone applications
Measured: 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
Measured: 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
Measured: through study completion during sleep, each sleep cycle about 6-8 hours
sleep time
total sleep time accessed by PSG and smart phone applications
Measured: through study completion during sleep, each sleep cycle about 6-8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890549
- Sponsor's protocol ID
- 201801799B0
- Status last verified
- Dec 2018
- First submitted
- 20 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Downloadable Mobile Snore Applications by Polysomnography
- ClinicalTrials.gov ID
- NCT03890549
- Acronym / sponsor ID
- 201801799B0
- Conditions
- Apnea, Obstructive, Snoring
- Keywords
- obstructive sleep apnea, polysomnography, smart phone application
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to validate the downloadable mobile snore applications by polysomnography.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive sleep apnea group | – | Diagnostic Test: SnoreLab (smart phone application for snoring recording)The patients were diagnosed by thoracic and ENT (Eye-Nose-Throat) specialist through polysomnography. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients diagnosed as obstructive sleep apnea no matter disease severity.
Key inclusion criteria (2 listed)
- Willing to sign inform consent with aged more than 20 years old
- Mild to moderate OSA, AHI (apnea-hypopnea index) < 30
Key exclusion criteria (5 listed)
- Significant lung disease
- Skeletal facial framework problems
- Central apnea
- Receiving acupuncture in recent 2 weeks
- Taking hypnotic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SnoreLab (smart phone application for snoring recording)Also: Sleep Cycle alarm clock (smart phone application for snoring recording), Anti Snore Solution (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. | Diagnostic test | obstructive sleep apnea group |
Primary outcome
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive and Snoring, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YUAN-CHIEH YEH, Doctor (24313131 ext. 2127, b9005030@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
snore time (time frame: through study completion during sleep, each sleep cycle about 6-8 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.