Obstructive Sleep ApneaNCT01355419
Sleep Schedules Modifications in Sleep Apnea Patients Treated by nCPAP
An observational study of Obstructive Sleep Apnea, run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial summary
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2010to Aug 2014
- Phase
- Observational
- 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
Study population: Moderate to severe OSA
Who may be able to join
- Moderate to severe OSA
- sleepy (sleepiness assessed by Epworth Sleepiness Scale)
- indication for CPAP therapy
Who cannot join
- narcolepsy
- age < 18
- non sleepy Moderate to severe OSA
- no CPAP treatment required
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.
Read the detailed description
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with CPAP therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Patients often report this fact, but it has not been objectivated.
Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients. Sleep schemes and physical activity will be studied with actigraphy.
Study Design : prospective study. Number of patients supposed to be studied: 190
Methods:
Patients Ø OSA patients assessed by polysomnography, showing apnea-hypopnea index > 20, and Epworth Sleepiness Scale Score(ESS) >10 Ø Indication of CPAP therapy
Initial Evaluation :
- Phase 1
- ESS
- BMI
- Questionnaire : Nottingham health profile
- Comorbidities -medical therapy
- Smoking/alcohol Consumption
- Then, we give an Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days
- Phase 2
- Actigraphy report
- Start of CPAP therapy(pressure adjusted according to autoCPAP device report after minimum one night)
Second Evaluation, after 3 months under CPAP:
- Phase 1 § ESS
- BMI
- CPAP observance report to calculate mean use/day
- Questionnaire : Nottingham health profile
- Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days
- Phase 2: after 1 week under CPAP and actigraphy
- Actigraphy report
- CPAP observance report
- CPAP Tolerance Questionnaire Ø
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, CPAP, actigraphy, sleep, physical activity
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| obstructive sleep apnea, CPAP | moderate to severe obstructive sleep apnea requiring CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
Measured: baseline and at 3 months
Secondary outcomes (1)
Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients
Change in Physical activity (number of steps/day)before and after CPAP therapy in OSA patientsevaluated by actigraphy
Measured: baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2011 (estimated)
- Study startAug 2010
- Primary completionAug 2014
- Study completionAug 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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT01355419
- Sponsor's protocol ID
- AK/10-07-45/3912
- Status last verified
- Apr 2015
- First submitted
- 6 May 2011
- Last updated
- 12 May 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 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep Schedules Modifications in Moderate to Severe Sleep Apnea Patients Treated by nCPAP
- ClinicalTrials.gov ID
- NCT01355419
- Acronym / sponsor ID
- AK/10-07-45/3912
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, CPAP, actigraphy, sleep, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 18 May 2011 (estimated)
- Results
- Posted 12 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with continuous positive airway pressure (CPAP) therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients.
Detailed description
In Obstructive sleep apnea (OSA) patients, sleep is disrupted and sleep quality is very poor. The investigators can suppose that with CPAP therapy, there is an improvement in sleep quality, such that patients need less sleep to be fit. Patients often report this fact, but it has not been objectivated.
Sleep schedules on mid term periods in OSA patients under CPAP therapy has not been studied. The investigators have planned to study sleep schemes before and after CPAP therapy in moderate to severe sleepy OSA patients. Sleep schemes and physical activity will be studied with actigraphy.
Study Design : prospective study. Number of patients supposed to be studied: 190
Methods:
Patients Ø OSA patients assessed by polysomnography, showing apnea-hypopnea index > 20, and Epworth Sleepiness Scale Score(ESS) >10 Ø Indication of CPAP therapy
Initial Evaluation :
- Phase 1
- ESS
- BMI
- Questionnaire : Nottingham health profile
- Comorbidities -medical therapy
- Smoking/alcohol Consumption
- Then, we give an Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days
- Phase 2
- Actigraphy report
- Start of CPAP therapy(pressure adjusted according to autoCPAP device report after minimum one night)
Second Evaluation, after 3 months under CPAP:
- Phase 1 § ESS
- BMI
- CPAP observance report to calculate mean use/day
- Questionnaire : Nottingham health profile
- Actigraph (Body Media Sense WearÒ) to the patients, that he has to wear during 7 complete days
- Phase 2: after 1 week under CPAP and actigraphy
- Actigraphy report
- CPAP observance report
- CPAP Tolerance Questionnaire Ø
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive sleep apnea, CPAP | – | –moderate to severe obstructive sleep apnea requiring CPAP therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to severe OSA
Key inclusion criteria (3 listed)
- Moderate to severe OSA
- sleepy (sleepiness assessed by Epworth Sleepiness Scale)
- indication for CPAP therapy
Key exclusion criteria (4 listed)
- narcolepsy
- age < 18
- non sleepy Moderate to severe OSA
- no CPAP treatment required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients
Time frame: baseline and at 3 months
change in Total sleep time before and after CPAP therapy in obstructive sleep apnea patients, assessed by actigraphy
1 secondary outcome
Change in Physical Activity (Number of Steps/Day)Before and After CPAP Therapy in OSA Patients
Time frame: baseline and at 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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?
An observational study of 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 3 inclusion and 4 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 12 May 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 12 May 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?
Change in Total Sleep Time Before and After CPAP Therapy in Obstructive Sleep Apnea Patients (time frame: baseline and at 3 months). 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 12 May 2015.