Obstructive Sleep ApneasleepboxNCT01471626
Real-time Attended Home-polysomnography Through Telematic Data Transmission
A study testing polysomnograph Dream and Sleep Box in people with Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- polysomnograph Dream and Sleep Box
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2011to Mar 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical suspicion of OSA
- 18 y old
Who cannot join
- restrictive respiratory disorders
- distance home-hospital exceeding 30 Km.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- polysomnograph Dream and Sleep Box
- Keywords
- sleep apnea, polysomnography, telemedicine
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polysomnograph Dream and Sleep BoxDevice
Portable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab.
| Study group | Role | What they receive |
|---|---|---|
| telematic attended polysomnography | Experimental | Not described Receives: Device: polysomnograph Dream and Sleep Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Polysomnographic Recordings
Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionFeb 2012
- Study completionMar 2012
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 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
- NCT01471626
- Sponsor's protocol ID
- AK/-10-81/4077
- Acronym
- sleepbox
- Status last verified
- Sep 2012
- First submitted
- 10 Oct 2011
- Last updated
- 5 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Attended Home-polysomnography Through Telematic Data Transmission
- ClinicalTrials.gov ID
- NCT01471626
- Acronym / sponsor ID
- sleepbox / AK/-10-81/4077
- Conditions
- Obstructive Sleep Apnea
- Keywords
- sleep apnea, polysomnography, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 15 Nov 2011 (estimated)
- Results
- Posted 5 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop an efficient home-based polysomnography device, which allows, through GPRS,continuous real-time monitoring from the sleep lab based in the hospital, in order to decrease the failure rate of home-based recordings.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| telematic attended polysomnography | Experimental | Device: polysomnograph Dream and Sleep Box |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical suspicion of OSA
- 18 y old
Key exclusion criteria (2 listed)
- restrictive respiratory disorders
- distance home-hospital exceeding 30 Km.
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 |
|---|---|---|
| polysomnograph Dream and Sleep BoxPortable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab. | Device | telematic attended polysomnography |
Primary outcome
Quality of Polysomnographic Recordings
Time frame: 1 week
Quality of recordings will be graded according to Redline S et al (SLEEP 1998): Unsatisfactory, poor, fair, good, very good,excellent. Unsatisfactory and poor recordings are considered as failures.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2012.
- 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 polysomnograph Dream and Sleep Box in people with Obstructive Sleep Apnea, 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 2 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 5 Oct 2012. 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 5 Oct 2012). 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?
Quality of Polysomnographic Recordings (time frame: 1 week). 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 5 Oct 2012.