ClinicalTrials.gg
Status unknownNCT01552083Updated Mar 13, 2012

A Community Pharmacist-led Intervention to Improve Screening of Sleep Apnea in Primary Care

An interventional study of screening of sleep apnea in Sleep Apnea, sponsored by Institut National de la Santé Et de la Recherche Médicale, France. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2012-03-13.

Sponsored by Institut National de la Santé Et de la Recherche Médicale, France · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Mar 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Not applicable
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sleep Apnea

Keywords

  • sleep apnea
  • screening
  • community pharmacy
03

In context

Sleep Apnea Syndromes

2,183 studies on the registry are indexed under Sleep Apnea Syndromes; 284 are open to participants now.

This study's planned enrollment of 400 is above the median of 53 across 1,400 interventional studies indexed under Sleep Apnea Syndromes.

Browse Sleep Apnea Syndromes studies →

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France is the lead sponsor of 376 studies on the registry; 80 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Taking 1 or more anti-hypertension drugs
  • Overweight (BMI > 25)
  • Snoring
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • To have a sleep apnea treatment
  • Not to have a referent doctor
  • To have a long-term illness
  • Did not sign informed consent
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
400 participants (estimated)

Interventions

  • Otherscreening of sleep apnea

    2 validated screening questionnaires (Berlin questionnaire, Epworth scale)

06

What researchers measure

Primary outcomes

  1. Proportion of patients referred by the general practitioner to sleep specialist for SAS diagnosis test

    Time frame: 6 months after the intervention of pharmacists.

Secondary outcomes

  1. Satisfaction of patients and pharmacists

    Time frame: 6 months after the intervention of pharmacist

  2. Proportion of patients with sleep apnea

    Time frame: 6 months after the intervention of pharmacists

07

Study locations

1 of 1 sites recruiting
  • Cermes3, CNRS UMR8211 - Inserm U988
    Villejuif, 94800, France
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2012, a primary completion of Jun 2012 and a completion of Dec 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2012
First posted
Mar 13, 2012
Start
Jan 2012
Primary completionEst.
Jun 2012
CompletionEst.
Dec 2012
Last update
Mar 13, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01552083
Collaborators
Centre National de la Recherche Scientifique, France
Responsible party
Sponsor
First posted
Mar 13, 2012
Start date
Jan 2012
Primary completion
Jun 2012 (estimated)
Completion
Dec 2012 (estimated)
Last update
Mar 13, 2012

Study contacts

Nathalie Pelletier-Fleury
Contact
npfleury@vjf.cnrs.fr
+33149583325
Clémence Perraudin
Contact
clemence.perraudin@gmail.com
+33149583486
Nathalise Pelletier-Fleury
principal investigator · Institut National de la Santé Et de la Recherche Médicale, France
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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