NCT01552083

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

January 27, 2012

Last Update Submit

March 12, 2012

Conditions

Keywords

sleep apneascreeningcommunity pharmacy

Outcome Measures

Primary Outcomes (1)

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

    6 months after the intervention of pharmacists.

Secondary Outcomes (2)

  • Satisfaction of patients and pharmacists

    6 months after the intervention of pharmacist

  • Proportion of patients with sleep apnea

    6 months after the intervention of pharmacists

Interventions

2 validated screening questionnaires (Berlin questionnaire, Epworth scale)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cermes3, CNRS UMR8211 - Inserm U988

Villejuif, 94800, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Nathalise Pelletier-Fleury

    Institut National de la Santé Et de la Recherche Médicale, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Pelletier-Fleury

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2012

First Posted

March 13, 2012

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

December 1, 2012

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations