Obstructive Sleep ApneaNCT02765958
Analyze Sleep Stages by Portable ECG Device
An observational study of Obstructive Sleep Apnea, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- portable ECG devise
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 May 2016to 2 Aug 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: outpatient in chest clinic
Who may be able to join
- OSA: OPD OSA patients; Healthy: no OSA
Who cannot join
- heart disease
- arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. In clinical settings, the analysis of daily sleep quality depends on actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really convenient for patients. In this trial, the investigators will measure the subjects' ECG signal and movement using a portable ECG device with motion sensor. On the other hand, the sleep stages are also obtained from the current wide-established measurement- polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our algorithm of artificial neural network. Then, the investigators can obtain the preliminary analysis of sleep quality can be obtained by using ECG device with our algorithm. It is helpful for doctors to realize the patent's sleep quality quickly
- Conditions
- Obstructive Sleep Apnea
- Being tested
- portable ECG devise
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable ECG deviseDevice
| Study group | Role | What they receive |
|---|---|---|
| Healthy | subjects without heart disease or arrhythmia, no evidence of obstructive sleep apnea Receives: Device: portable ECG devise | |
| OSA | obstructive sleep apnea Receives: Device: portable ECG devise |
What is being measured
The primary outcome is the main question the study is designed to answer.
RR interval changes compared to the report of polysomography
The difference of RR interval in healthy subjects and obstructive sleep apnea subjects
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study start4 May 2016
- Primary completion27 Feb 2017
- Study completion2 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping-Huai Wang, Far Eastern Memorial Hospital
- Investigators
- Ping-huai Wang, MD, Principal investigator, Far Eastern Memeorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765958
- Sponsor's protocol ID
- FEMH-104181-F
- Status last verified
- Feb 2018
- First submitted
- 4 May 2016
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyze Sleep Stages by Portable ECG Device
- ClinicalTrials.gov ID
- NCT02765958
- Acronym / sponsor ID
- FEMH-104181-F
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 4 May 2016 (actual)
- Primary completion
- 27 Feb 2017 (actual)
- Study completion
- 2 Aug 2017 (actual)
- First posted
- 9 May 2016 (estimated)
- 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.
Sleep is a fundamental need for human and is associated with the working performance and the disease occurrence. Furthermore, the amount of people with sleep disorder or apnea increased largely. Thus, the analysis of sleep stages and the measurement of sleep quality became more important recently. In clinical settings, the analysis of daily sleep quality depends on actigraphy and sleep log. However, the uses of actigraphy and sleep log are not really convenient for patients. In this trial, the investigators will measure the subjects' ECG signal and movement using a portable ECG device with motion sensor. On the other hand, the sleep stages are also obtained from the current wide-established measurement- polysomnography. The ECG signals, movements, and sleep stages will be analyzed by our algorithm of artificial neural network. Then, the investigators can obtain the preliminary analysis of sleep quality can be obtained by using ECG device with our algorithm. It is helpful for doctors to realize the patent's sleep quality quickly
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | Device: portable ECG devisesubjects without heart disease or arrhythmia, no evidence of obstructive sleep apnea |
| OSA | – | Device: portable ECG deviseobstructive sleep apnea |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient in chest clinic
Key inclusion criteria (1 listed)
- OSA: OPD OSA patients; Healthy: no OSA
Key exclusion criteria (2 listed)
- heart disease
- arrhythmia
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 |
|---|---|---|
| portable ECG devise | Device | Healthy, OSA |
Primary outcome
RR interval changes compared to the report of polysomography
Time frame: 8 hours
The difference of RR interval in healthy subjects and obstructive sleep apnea subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Individual participant dataSharing planned: Yes
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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.
Ping-huai Wang, MD principal investigator
Far Eastern Memeorial Hospital
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 Obstructive Sleep Apnea, run by Far Eastern 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 8 Feb 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RR interval changes compared to the report of polysomography (time frame: 8 hours). 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 8 Feb 2018.