Sleep Apnea SyndromesNCT02435355
Efficiency of a Phone Coaching for Sleep Apnea Hypopnea Syndrome Patients
A study testing telephone-based counselling in people with Sleep Apnea Syndromes, run by Sadir Association.
Trial summary
Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the treatment appears to be a key factor to improving health status of these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- telephone-based counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Oct 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- newly diagnosed with SAHS
- CPAP treatment prescribed
Who cannot join
- previously use CPAP
About this study
Official title: Efficiency of a Phone Coaching Program on Adherence to Continuous Positive Airway Pressure in Sleep Apnea Hypopnea Syndrome
Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the treatment appears to be a key factor to improving health status of these patients.
Methods: The investigators conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support completed or not within 3 months of coaching sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session consisted of 5 sessions of telephone-based counseling by competent staff. The primary outcome was the proportion of patients using CPAP more than 3 hours per night for 4 months; the secondary outcome was mean hours of CPAP usage in the 2 groups.
Read the detailed description
We conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support versus phone coaching for newly diagnosed SAHS patients starting CPAP therapy. Patients for clinical polysomnographic evaluation were recruited from April 2010 to March 2012. Those who were subsequently diagnosed with SAHS and prescribed CPAP were included in the study. The patient population was then randomized into two groups, one that received standard CPAP support only and the other standard support completed by a coaching session.
Procedure Standard support All patients in this study underwent this procedure, which is the regular procedure in France. In short, the patient received information by their physician, about modalities and usefulness of CPAP treatment. In the week following this information, a technician from the home care provider (SADIR based in France) brought CPAP equipment to the home, re-explained the device function and checked the mask adaptation to the patient. The follow-up of the patient by the home care provider consisted of one visit at home the first month to check the mask's tolerance and the functioning of the machine. An other visit was performed after 4 months to assess CPAP parameters (length of use, mask leaks, and residual AHI). Sleep physician checked the compliance and efficiency of CPAP treatment once the first month, then at 3 and 6 months. The compliance was then assessed by patient questioning and by looking at the data registered by the machine. After this period, the medical follow up was performed once a year.
Coached group In the coached group (CG), patients received standard support completed by 5 sessions (day 3, 10, 30, 60, 90 with equipment at home) of telephone-based counselling session by competent staff. Sessions were performed by a qualified person in education, qualifies by a university degree (Paul Sabatier University, Toulouse, France). The dates of phone calls were planned with the patient availabilities.
The objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits. The qualified person in education could also refer any problems in links with SAHS encountered by the patient to the technician, psychologist or dietician (employed by the home care provider). They can respectively help the patient with CPAP technical advice, mentally blocked with CPAP or diet counseling. The average length of each phone call was approximately 15 to 20 minutes.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- telephone-based counselling
- Keywords
- Sleep apnea, education, compliance, CPAP
- Medical subject headings
- Sleep Apnea Syndromes, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telephone-based counsellingBehavioural
The objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits.
| Study group | Role | What they receive |
|---|---|---|
| standard support | No intervention | All patients in this study underwent this procedure, which is the regular procedure in France. |
| coached group | Experimental | In the coached group (CG), patients received standard support completed by 5 sessions (day 3, 10, 30, 60, 90 with equipment at home) of telephone-based counselling session by competent staff. Sessions were performed by a qualified person in education, qualifies by a university degree (Paul Sabatier University, Toulouse, France). The dates of phone calls were planned with the patient availabilities. Receives: Behavioral: telephone-based counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups
Measured: CPAP use was evaluated for 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2015 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sadir Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02435355
- Sponsor's protocol ID
- Sadir Association
- Status last verified
- Apr 2015
- First submitted
- 30 Apr 2015
- Last updated
- 6 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sedkaoui K, Leseux L, Pontier S, Rossin N, Leophonte P, Fraysse JL, Didier A. Efficiency of a phone coaching program on adherence to continuous positive airway pressure in sleep apnea hypopnea syndrome: a randomized trial. BMC Pulm Med. 2015 Sep 14;15:102. doi: 10.1186/s12890-015-0099-7.
PubMed 26370444
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of a Phone Coaching Program on Adherence to Continuous Positive Airway Pressure in Sleep Apnea Hypopnea Syndrome
- ClinicalTrials.gov ID
- NCT02435355
- Acronym / sponsor ID
- Sadir Association
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep apnea, education, compliance, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Sadir AssociationUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 May 2015 (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.
Background: Continuous Positive Airway Pressure (CPAP) remains the reference treatment for moderate to severe forms of the Sleep Apnea/Hypopnea Syndrome (SAHS). Compliance to the treatment appears to be a key factor to improving health status of these patients.
Methods: The investigators conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support completed or not within 3 months of coaching sessions for newly diagnosed SAHS patients starting CPAP therapy. The coaching session consisted of 5 sessions of telephone-based counseling by competent staff. The primary outcome was the proportion of patients using CPAP more than 3 hours per night for 4 months; the secondary outcome was mean hours of CPAP usage in the 2 groups.
Detailed description
We conducted a multicenter, prospective, randomized, controlled, parallel group trial of standard support versus phone coaching for newly diagnosed SAHS patients starting CPAP therapy. Patients for clinical polysomnographic evaluation were recruited from April 2010 to March 2012. Those who were subsequently diagnosed with SAHS and prescribed CPAP were included in the study. The patient population was then randomized into two groups, one that received standard CPAP support only and the other standard support completed by a coaching session.
Procedure Standard support All patients in this study underwent this procedure, which is the regular procedure in France. In short, the patient received information by their physician, about modalities and usefulness of CPAP treatment. In the week following this information, a technician from the home care provider (SADIR based in France) brought CPAP equipment to the home, re-explained the device function and checked the mask adaptation to the patient. The follow-up of the patient by the home care provider consisted of one visit at home the first month to check the mask's tolerance and the functioning of the machine. An other visit was performed after 4 months to assess CPAP parameters (length of use, mask leaks, and residual AHI). Sleep physician checked the compliance and efficiency of CPAP treatment once the first month, then at 3 and 6 months. The compliance was then assessed by patient questioning and by looking at the data registered by the machine. After this period, the medical follow up was performed once a year.
Coached group In the coached group (CG), patients received standard support completed by 5 sessions (day 3, 10, 30, 60, 90 with equipment at home) of telephone-based counselling session by competent staff. Sessions were performed by a qualified person in education, qualifies by a university degree (Paul Sabatier University, Toulouse, France). The dates of phone calls were planned with the patient availabilities.
The objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits. The qualified person in education could also refer any problems in links with SAHS encountered by the patient to the technician, psychologist or dietician (employed by the home care provider). They can respectively help the patient with CPAP technical advice, mentally blocked with CPAP or diet counseling. The average length of each phone call was approximately 15 to 20 minutes.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard support | No intervention | –All patients in this study underwent this procedure, which is the regular procedure in France. |
| coached group | Experimental | Behavioral: telephone-based counsellingIn the coached group (CG), patients received standard support completed by 5 sessions (day 3, 10, 30, 60, 90 with equipment at home) of telephone-based counselling session by competent staff. Sessions were performed by a qualified person in education, qualifies by a university degree (Paul Sabatier University, Toulouse, France). The dates of phone calls were planned with the patient availabilities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- newly diagnosed with SAHS
- CPAP treatment prescribed
Key exclusion criteria (1 listed)
- previously use CPAP
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 |
|---|---|---|
| telephone-based counsellingThe objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits. | Behavioural | coached group |
Primary outcome
proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups
Time frame: CPAP use was evaluated for 4 months
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 May 2015.
- Derived from this study: PubMed 26370444Sedkaoui K, Leseux L, Pontier S, Rossin N, Leophonte P, Fraysse JL, Didier A. Efficiency of a phone coaching program on adherence to continuous positive airway pressure in sleep apnea hypopnea syndrome: a randomized trial. BMC Pulm Med. 2015 Sep 14;15:102. doi: 10.1186/s12890-015-0099-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing telephone-based counselling in people with Sleep Apnea Syndromes, run by Sadir Association.
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 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 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
proportion of patients using Continuous Positive Airway Pressure for more than 3 hours per night in the 2 groups (time frame: CPAP use was evaluated for 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02435355, which also lists 1 linked publication.
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 May 2015.