Sleep ApneaNCT00425659
Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea
A study testing home sleep study, home CPAP titration (Autoset) and CPAP in people with Sleep Apnea, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- home sleep study, home CPAP titration (Autoset) and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Jan 2007to Jun 2009
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with high pretest probability of OSAS, i.e. ESS > 10 or symptomatic patients, with BMI > 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
- Patients aged between 18-65 years who agree to participate in the study.
Who cannot join
- Pregnant women
- Patients who refuse signing consent of the study
- Do not have high pretest probability of OSAS
- Refuse to have home sleep study
- Refuse any treatment offered; or
- Could not comply with the set up of home study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients
Read the detailed description
Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.
Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.
Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.
Interventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.
Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.
- Conditions
- Sleep Apnea
- Being tested
- home sleep study, home CPAP titration (Autoset), CPAP
- Keywords
- Health utility, Home sleep study
- 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.
home sleep studyDevice
Also called different algorithm arrangement
different in algorithm arrangement for diagnosing sleep apnea
home CPAP titration (Autoset)Device
Also called Autoset
continuous positive airway pressure device for treatment of sleep apnea
CPAPDevice
usual practice
| Study group | Role | What they receive |
|---|---|---|
| 3 | Active comparator | Not described Receives: Device: home CPAP titration (Autoset) |
| 1 | Experimental | Not described Receives: Device: home sleep study |
| 2 | Other | usual practice Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of the new home sleep study device compare with conventional inpatient sleep study
Measured: 1 year
Secondary outcomes (2)
The relative efficacy between different algorithm
Measured: 1 year
Failure rates in different algorithms which need to switch to the conventional algorithm
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 posted23 Jan 2007 (estimated)
- Study startJan 2007
- Primary completionMar 2009
- Study completionJun 2009
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Kin W To, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00425659
- Sponsor's protocol ID
- CRE-2006.404-T
- Status last verified
- Jul 2009
- First submitted
- 22 Jan 2007
- Last updated
- 10 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Diagnostic and Treatment Algorithm for Obstructive Sleep Apnea in High Risk Population in Hong Kong
- ClinicalTrials.gov ID
- NCT00425659
- Acronym / sponsor ID
- CRE-2006.404-T
- Conditions
- Sleep Apnea
- Keywords
- Health utility, Home sleep study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Jan 2007 (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.
Newer home sleep study device and algorithm provides an alternative for inpatient sleep study and improve the service provides to patients
Detailed description
Purpose: Assess different potential algorithms to improve the service and cost utility for diagnosis and treatment of obstructive sleep apnea syndrome (OSAS) in patients with high pretest probability in Hong Kong.
Hypothesis: Newer home sleep study device and algorithm provides an alternative for inpatient sleep study Design: Prospective randomized study Subject: High pretest probability of OSAS patients referred to a tertiary centre.
Study instruments: a portable sleep study device, AutoCPAP and inpatient sleep monitoring system.
Interventions: comparison between 3 different algorithms of health service for OSA patients would be made: conventional in-patient sleep study, empirical treatment and home sleep study.
Main outcome measures: The primary outcome is the validity of the home sleep study device compare to inpatient sleep study. The secondary outcomes are the relative efficacy of different algorithms and the numbers of failed procedures in each algorithm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 | Active comparator | Device: home CPAP titration (Autoset) |
| 1 | Experimental | Device: home sleep study |
| 2 | Other | Device: CPAPusual practice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients with high pretest probability of OSAS, i.e. ESS > 10 or symptomatic patients, with BMI > 23 and/or cranial facial features associated with OSA, as assessed by the attending respiratory physician in the respiratory clinic.
- Patients aged between 18-65 years who agree to participate in the study.
Key exclusion criteria (6 listed)
- Pregnant women
- Patients who refuse signing consent of the study
- Do not have high pretest probability of OSAS
- Refuse to have home sleep study
- Refuse any treatment offered; or
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 |
|---|---|---|
| home sleep studyAlso: different algorithm arrangementdifferent in algorithm arrangement for diagnosing sleep apnea | Device | 1 |
| home CPAP titration (Autoset)Also: Autosetcontinuous positive airway pressure device for treatment of sleep apnea | Device | 3 |
| CPAPusual practice | Device | 2 |
Primary outcome
Validity of the new home sleep study device compare with conventional inpatient sleep study
Time frame: 1 year
2 secondary outcomes
The relative efficacy between different algorithm
Time frame: 1 year
Failure rates in different algorithms which need to switch to the conventional algorithm
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 10 Jul 2009.
Related trials for Sleep Apnea
RecruitingObservational study
Oura Ring OA15 Validation
Healthy Adult, Sleep Apnea
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingPhase 2/3
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
Sleep Apnoea, Obesity & Overweight
Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
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.
Kin W To, 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?
A study testing home sleep study, home CPAP titration (Autoset) and CPAP in people with 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 2 inclusion and 6 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 10 Jul 2009. 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 the new home sleep study device compare with conventional inpatient sleep study (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 10 Jul 2009.