Sleep Apnea SyndromesNCT03157440
Novel Device for Screening Patients With Symptoms of OSA
An observational study of Sleep Apnea Syndromes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Ring oxymetry
- How many people
- 97 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Apr 2017to 31 Mar 2018
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with symptoms of OSA who will be undergoing sleep study for establishing a diagnosis
Who may be able to join
- Patients above 18 years old and below 70 years old, both men and women
Who cannot join
- Patients requiring oxygen therapy or noninvasive ventilation;
- Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy.
- Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Hong Kong
About this study
Official title: Validation of a Novel Device for Screening Patients With Symptoms of OSA
An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Ring oxymetry
- 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.
Ring oxymetryDiagnostic test
a new type oxymetry wear on index finger like a ring
What is being measured
The primary outcome is the main question the study is designed to answer.
the concordance of the ring oximetry with PSG as the gold standard
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 posted17 May 2017
- Study start1 Apr 2017
- Primary completion31 Aug 2017
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromesStudies 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, To Kin Wang, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03157440
- Sponsor's protocol ID
- 2016.661
- Status last verified
- Apr 2019
- First submitted
- 16 May 2017
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Novel Device for Screening Patients With Symptoms of OSA
- ClinicalTrials.gov ID
- NCT03157440
- Acronym / sponsor ID
- 2016.661
- Conditions
- Sleep Apnea Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 17 May 2017 (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.
An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate it's accuracy and usefulness as a screening device for patients with symptoms of OSA
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with symptoms of OSA who will be undergoing sleep study for establishing a diagnosis
Key inclusion criteria (1 listed)
- Patients above 18 years old and below 70 years old, both men and women
Key exclusion criteria (3 listed)
- Patients requiring oxygen therapy or noninvasive ventilation;
- Patients with a diagnosis of chronic obstructive pulmonary disease, chronic heart failure, neuromuscular disease, insomnia, clinical symptoms of parasomnia, periodic limb movement, or narcolepsy.
- Patients on medication known to interfere with heart rate, such as beta-blockers, digoxin or calcium receptor antagonists.
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 |
|---|---|---|
| Ring oxymetrya new type oxymetry wear on index finger like a ring | Diagnostic test | – |
Primary outcome
the concordance of the ring oximetry with PSG as the gold standard
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 17 Apr 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syndromes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 3 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 17 Apr 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 Hong Kong. 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?
the concordance of the ring oximetry with PSG as the gold standard (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 17 Apr 2019.