Sleep Apnea SyndromeCoachSASNCT02657304
Effect of Early Education on the Observance of CPAP Treatment
A study testing Coaching group in people with Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sleep Apnea Syndrome
- What is being tested?
- Coaching group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Mar 2016to 12 Jan 2021
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients affiliated or entitled to a French medical insurance
- Patients of both gender, aged from 18 to 80 years
- Patients with AHI > 30/hour or between 15 \& 30/h with Sleep Fragmentation Index (SFI) of more than 10/h
- Signature of consent
Who cannot join
- Known diseases which contraindicated used of CPAP treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment
Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.
Read the detailed description
Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.
The investigators hypothesize that an early education and information of SA (in the first 2 weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of CPAP (> 5 h/night).
Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).
- Conditions
- Sleep Apnea Syndrome
- Being tested
- Coaching group, Control group
- Keywords
- Sleep Apnea, CPAP
- 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.
Coaching groupBehavioural
patients will have a medical consultation at 2 weeks post-diagnostic and one phone call/month for duration of 5 months. The consultations will use visual support, CPAP device and its accessories.
Control groupOther
patients receive only usual care (standard), it's mean: diagnosis with explanation of the disease and benefit of CPAP, entrusts a medical device provider, then an appointment proposed by the doctor or taken by the patient (5 months).
| Study group | Role | What they receive |
|---|---|---|
| Coaching group | Experimental | PPC + Coaching Receives: Behavioral: Coaching group |
| Control group | Active comparator | PPC Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observance
Percentage of patients with a mean duration of observance of more than 5h/night after five months of follow-up in the coached and the control groups
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study start21 Mar 2016
- Primary completionJan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric ROCHE, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657304
- Sponsor's protocol ID
- 1508146
- Other IDs
- 2015-A01635-44
- Acronym
- CoachSAS
- Status last verified
- Aug 2021
- First submitted
- 13 Jan 2016
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment
- ClinicalTrials.gov ID
- NCT02657304
- Acronym / sponsor ID
- CoachSAS / 1508146
- Conditions
- Sleep Apnea Syndrome
- Keywords
- Sleep Apnea, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 21 Mar 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 15 Jan 2016 (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.
Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.
Detailed description
Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.
The investigators hypothesize that an early education and information of SA (in the first 2 weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of CPAP (> 5 h/night).
Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching group | Experimental | Behavioral: Coaching groupPPC + Coaching |
| Control group | Active comparator | Other: Control groupPPC |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients affiliated or entitled to a French medical insurance
- Patients of both gender, aged from 18 to 80 years
- Patients with AHI > 30/hour or between 15 \& 30/h with Sleep Fragmentation Index (SFI) of more than 10/h
- Signature of consent
Key exclusion criteria (1 listed)
- Known diseases which contraindicated used of CPAP treatment
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 |
|---|---|---|
| Coaching grouppatients will have a medical consultation at 2 weeks post-diagnostic and one phone call/month for duration of 5 months. The consultations will use visual support, CPAP device and its accessories. | Behavioural | Coaching group |
| Control grouppatients receive only usual care (standard), it's mean: diagnosis with explanation of the disease and benefit of CPAP, entrusts a medical device provider, then an appointment proposed by the doctor or taken by the patient (5 months). | Other | Control group |
Primary outcome
Observance
Time frame: 5 months
Percentage of patients with a mean duration of observance of more than 5h/night after five months of follow-up in the coached and the control groups
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 6 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea Syndrome
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
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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
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.
Frédéric ROCHE, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching group in people with Sleep Apnea Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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 1 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 6 Aug 2021. 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 France. 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?
Observance (time frame: 5 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 6 Aug 2021.