Sleep ApneaNCT01552083
A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care
A study testing screening of sleep apnea in people with Sleep Apnea, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea screening program for patients at risk in community pharmacies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- screening of sleep apnea
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Dec 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Taking 1 or more anti-hypertension drugs
- Overweight (BMI > 25)
- Snoring
- Signed informed consent
Who cannot join
- To have a sleep apnea treatment
- Not to have a referent doctor
- To have a long-term illness
- Did not sign informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Cermes3, CNRS UMR8211 - Inserm U988
Villejuif, 94800
Nathalie Pelletier-Fleury, +33149583325, npfleury@vjf.cnrs.fr
Clémence Perraudin, +33149583486, clemence.perraudin@gmail.com
About this study
The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea screening program for patients at risk in community pharmacies.
Read the detailed description
Background: The sleep apnea syndrome (SAS) is a common disease but unknown. According to epidemiological studies, approximately 5% to 10% of the general population is living with SAS. Untreated sleep apnea has an important individual impact: it is accompanied by sleep disturbances and vigilance and frequent co-morbidities such as hypertension, diabetes or other cardiovascular diseases. Also, it has a cost to the community due to significant traffic accidents and work accidents more frequent in this population and weight for health insurance for cardiovascular diseases. However, its screening and its management remain largely insufficient. The report of the Ministry of Health in 2006 estimated that only 15% of subjects with a SAS would be diagnosed.
The Law "Hospital, Patients, Health and Territories" (HPST) in 2009 provides pharmacists with new responsibilities in the health screening, care coordination, or in therapeutic education (Article 38 of Law HPST).
Objective: In this dual context, this study aims to assess the feasibility and effectiveness of an information campaign and screening of SAS in patients at risk in the community pharmacies. The investigators analyze whether the involvement of community pharmacists in the care pathway of a patient at risk is effective, that is to say if it improves the detection rate and diagnostic the disease in this population.
Project Description: 400 patients at risk of SAS will be recruited by the participating pharmacists. Screening intervention consists in 2 validated questionnaires which evaluate SAS risk (Berlin Questionnaire, Epworth Sleepiness Scale). Pharmacist distributes also an information leaflet about SAS, and refers patient to general practitioner with questionnaires results. Patients are followed by the pharmacists for 6 months.
- Conditions
- Sleep Apnea
- Being tested
- screening of sleep apnea
- Keywords
- sleep apnea, screening, community pharmacy
- 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.
screening of sleep apneaOther
2 validated screening questionnaires (Berlin questionnaire, Epworth scale)
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test
Measured: 6 months after the intervention of pharmacists.
Secondary outcomes (2)
Satisfaction of patients and pharmacists
Measured: 6 months after the intervention of pharmacist
Proportion of patients with sleep apnea
Measured: 6 months after the intervention of pharmacists
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Sponsor
- Investigators
- Nathalise Pelletier-Fleury, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552083
- Sponsor's protocol ID
- Etude SAS
- Status last verified
- Mar 2012
- First submitted
- 27 Jan 2012
- Last updated
- 13 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care
- ClinicalTrials.gov ID
- NCT01552083
- Acronym / sponsor ID
- Etude SAS
- Conditions
- Sleep Apnea
- Keywords
- sleep apnea, screening, community pharmacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Mar 2012 (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.
The purpose of this study is to evaluate the feasibility and the effectiveness of sleep apnea screening program for patients at risk in community pharmacies.
Detailed description
Background: The sleep apnea syndrome (SAS) is a common disease but unknown. According to epidemiological studies, approximately 5% to 10% of the general population is living with SAS. Untreated sleep apnea has an important individual impact: it is accompanied by sleep disturbances and vigilance and frequent co-morbidities such as hypertension, diabetes or other cardiovascular diseases. Also, it has a cost to the community due to significant traffic accidents and work accidents more frequent in this population and weight for health insurance for cardiovascular diseases. However, its screening and its management remain largely insufficient. The report of the Ministry of Health in 2006 estimated that only 15% of subjects with a SAS would be diagnosed.
The Law "Hospital, Patients, Health and Territories" (HPST) in 2009 provides pharmacists with new responsibilities in the health screening, care coordination, or in therapeutic education (Article 38 of Law HPST).
Objective: In this dual context, this study aims to assess the feasibility and effectiveness of an information campaign and screening of SAS in patients at risk in the community pharmacies. The investigators analyze whether the involvement of community pharmacists in the care pathway of a patient at risk is effective, that is to say if it improves the detection rate and diagnostic the disease in this population.
Project Description: 400 patients at risk of SAS will be recruited by the participating pharmacists. Screening intervention consists in 2 validated questionnaires which evaluate SAS risk (Berlin Questionnaire, Epworth Sleepiness Scale). Pharmacist distributes also an information leaflet about SAS, and refers patient to general practitioner with questionnaires results. Patients are followed by the pharmacists for 6 months.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Taking 1 or more anti-hypertension drugs
- Overweight (BMI > 25)
- Snoring
- Signed informed consent
Key exclusion criteria (4 listed)
- To have a sleep apnea treatment
- Not to have a referent doctor
- To have a long-term illness
- Did not sign informed consent
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 |
|---|---|---|
| screening of sleep apnea2 validated screening questionnaires (Berlin questionnaire, Epworth scale) | Other | – |
Primary outcome
Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test
Time frame: 6 months after the intervention of pharmacists.
2 secondary outcomes
Satisfaction of patients and pharmacists
Time frame: 6 months after the intervention of pharmacist
Proportion of patients with sleep apnea
Time frame: 6 months after the intervention of pharmacists
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2012.
Related trials for Sleep Apnea
RecruitingObservational study
Prevalence, Phenotypes, Predictors and Prognostic Implication of Obstructive Sleep Apnea in Pulmonary Hypertension
Sleep Apnea, Obstructive Sleep Apnea
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
Recruiting
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Physical Activity, Sleep Quality, and Respiratory Function in Obstructive Sleep Apnea
Obstructive Sleep Apnea, Sleep Quality
RecruitingPhase 4
Impact GLP-1 Agonists Following Bariatric
Morbid Obesity, Metabolic Syndrome
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.
Nathalise Pelletier-Fleury principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing screening of sleep apnea in people with Sleep Apnea, run by Institut National de la Santé Et de la Recherche Médicale, France 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 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: status not confirmed, as of the sponsor's last update on 13 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Pelletier-Fleury (+33149583325, npfleury@vjf.cnrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test (time frame: 6 months after the intervention of pharmacists.). 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 13 Mar 2012; AzTrials last refreshed its copy on 26 Oct 2026.