Sleep Disordered-breathingNCT01361854
Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
A study testing polysomnography in people with Sleep Disordered-breathing, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing. First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sleep Disordered-breathing
- What is being tested?
- polysomnography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2011to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult,
- suspects of SDB,
- leaving home,
- at maximum 30km around the hospital
Who cannot join
- suspicion of other sleep disorders
- children
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing.
First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring.
Second one: hook-up is performed home, around 7 PM, and the patient has not to move after hook-up.
Read the detailed description
All the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. Order of the exams will be randomized.
We hypothesised that quality of recording is better when hook-up is performed at home.
Final polysomnographic diagnosis, with the 2 different techniques, must be similar.
- Conditions
- Sleep Disordered-breathing
- Being tested
- polysomnography
- Keywords
- polysomnography, portable monitoring, sleep, sleep disordered breathing, home based polysomnography
- 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.
polysomnographyDevice
Also called sleep study
home-based polysomnography with hook-up performed ar at home or in the hospital
| Study group | Role | What they receive |
|---|---|---|
| polysomnography for suspicion of SDB | Experimental | adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography Receives: Device: polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure Rate of Sleep Study
failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startAug 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Disordered-breathingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Bruyneel, Centre Hospitalier Universitaire Saint Pierre
- Investigators
- marie Bruyneel, MD, Principal investigator, CHU St Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361854
- Sponsor's protocol ID
- AK/11-05-42/4024
- Status last verified
- May 2015
- First submitted
- 26 May 2011
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Different Hook-up Protocols to Perform Home-based Polysomnography
- ClinicalTrials.gov ID
- NCT01361854
- Acronym / sponsor ID
- AK/11-05-42/4024
- Conditions
- Sleep Disordered-breathing
- Keywords
- polysomnography, portable monitoring, sleep, sleep disordered breathing, home based polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of 2 hook-up protocols to perform home-based sleep studies in patients suspected of sleep-disordered breathing.
First one: hook-up is performed in the hospital, around 4 PM, and the patient go home with the portable monitoring.
Second one: hook-up is performed home, around 7 PM, and the patient has not to move after hook-up.
Detailed description
All the patients will undergo 2 polysomnographies, according to two different hook-up protocols, within 2 weeks. Order of the exams will be randomized.
We hypothesised that quality of recording is better when hook-up is performed at home.
Final polysomnographic diagnosis, with the 2 different techniques, must be similar.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polysomnography for suspicion of SDB | Experimental | Device: polysomnographyadults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult,
- suspects of SDB,
- leaving home,
- at maximum 30km around the hospital
Key exclusion criteria (2 listed)
- suspicion of other sleep disorders
- children
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 |
|---|---|---|
| polysomnographyAlso: sleep studyhome-based polysomnography with hook-up performed ar at home or in the hospital | Device | polysomnography for suspicion of SDB |
Primary outcome
Failure Rate of Sleep Study
Time frame: 1 day
failure rate of polysomnography according to the hook-up protocol. Polysomnographies scored as "poor" or "unsatisafctory" according to Redline et al. SLEEP 1998 are considered as failed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
marie Bruyneel, MD principal investigator
CHU St Pierre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polysomnography in people with Sleep Disordered-breathing, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
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 4 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 Jun 2015. 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 Belgium. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Failure Rate of Sleep Study (time frame: 1 day). 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 Jun 2015.