NCT01801592

Brief Summary

The main aim of this study is to determine how common undiagnosed obstructive sleep apnoea is in individuals with intermittent claudication.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 18, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 3, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 13, 2017

Completed
Last Updated

November 1, 2017

Status Verified

February 1, 2016

Enrollment Period

4.4 years

First QC Date

February 18, 2013

Last Update Submit

October 30, 2017

Conditions

Sleep Apnea

Keywords

OBSTRUCTIVE SLEEP APNOEAINTERMITTENT CLAUDICATIONRespiratory diseasePeripheral artery disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence of an Apnea hyponea index > 15

    Recording of sleep with the RESMED (Apnealink) system

    up to 2 months after inclusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

men or women over 18 years old with an Intermitent claudication.

You may qualify if:

  • Register to the social health insurance
  • Referred for a walk test because of claudication
  • Maximal walking ditance \< 750m
  • Older than 18 years old
  • Able to understand the protocol of the study

You may not qualify if:

  • Severe reparatory disease already known
  • Parkinson disease, hémiplégia ou paraplégia
  • Does not want to participate to the protocol
  • Pregnant women
  • Adults to enhanced protection, deprived of their liberty by judicial or administrative authority, without consent hospitalized or admitted to a health facility or social purposes other than research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital

Angers, 49933, France

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, ObstructiveIntermittent ClaudicationRespiration DisordersPeripheral Arterial Disease

Condition Hierarchy (Ancestors)

ApneaRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPeripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsAtherosclerosisArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Guillaume Mahe, MD; PhD

    University Hospital in Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

March 1, 2013

Study Start

May 3, 2013

Primary Completion

October 13, 2017

Study Completion

October 13, 2017

Last Updated

November 1, 2017

Record last verified: 2016-02

Locations

FR(1)