Sleep ApneaNCT00628511
Validation of Portable Monitoring Device for Diagnosing Sleep Apnea
An observational study of Sleep Apnea, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
portable monitoring device could diagnose sleep apnea in high risk patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- ARES (Apnea Risk Evaluation System)
- Type of treatment
- Medical device
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Feb 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients suspected of sleep apnea
Who may be able to join
- patients suspected of sleep apnea
Who cannot join
- patient refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Validation Study of A New Diagnostic Device for Screening of Obstructive Sleep Apnea in High Risk Patient Population
portable monitoring device could diagnose sleep apnea in high risk patients.
Read the detailed description
This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device.
Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity.
- Conditions
- Sleep Apnea
- Being tested
- ARES (Apnea Risk Evaluation System)
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARES (Apnea Risk Evaluation System)Device
application of portable monitoring device with PSG
| Study group | Role | What they receive |
|---|---|---|
| observation | Not described Receives: Device: ARES (Apnea Risk Evaluation System) |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of portable monitoring device
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJan 2007
- Primary completionDec 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- To K Wang, MBCHB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628511
- Sponsor's protocol ID
- 6902256
- Status last verified
- Feb 2008
- First submitted
- 6 Feb 2008
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of A New Diagnostic Device for Screening of Obstructive Sleep Apnea in High Risk Patient Population
- ClinicalTrials.gov ID
- NCT00628511
- Acronym / sponsor ID
- 6902256
- Conditions
- Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 5 Mar 2008 (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.
portable monitoring device could diagnose sleep apnea in high risk patients.
Detailed description
This is a pilot study of another larger cohort investigating different algorithms in managing patients suspected of sleep apnea using portable monitoring device.
Portable monitoring device is applied simultaneously with PSG to compare it's accuracy and validity.
Study design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | Device: ARES (Apnea Risk Evaluation System) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients suspected of sleep apnea
Key inclusion criteria (1 listed)
- patients suspected of sleep apnea
Key exclusion criteria (1 listed)
- patient refuse to participate
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 |
|---|---|---|
| ARES (Apnea Risk Evaluation System)application of portable monitoring device with PSG | Device | observation |
Primary outcome
validity of portable monitoring device
Time frame: 1 year
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 9 Feb 2016.
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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.
To K Wang, MBCHB principal investigator
Chinese University of Hong Kong
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 Sleep Apnea, run by Chinese University of Hong Kong at 1 site in China.
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 1 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 9 Feb 2016. 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 China. 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?
validity of portable monitoring device (time frame: 1 year). 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 9 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.