NCT02061046

Brief Summary

To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome.

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
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Longer than P75 for all trials

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

August 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

Same day

First QC Date

February 7, 2014

Last Update Submit

November 30, 2015

Conditions

Obstructive Sleep Apnea

Keywords

GaitDual task

Outcome Measures

Primary Outcomes (1)

  • Gait parameters: gait velocity [m/s]

    8 weeks

Study Arms (1)

On CPAP therapy

OSA patients assessed before and after 8 weeks of CPAP therapy

Device: CPAP therapy

Interventions

CPAP therapyDEVICE

8 weeks of CPAP therapy

On CPAP therapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

OSA patients without any prior treatment

You may qualify if:

  • OSA patients newly diagnosed

You may not qualify if:

  • acute medical illness in the past months
  • neurological and psychiatric diseases
  • orthopaedic, rheumatologic or any sensory conditions affecting normal walking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Gilles Allali, MD/PhD

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 12, 2014

Study Start

August 1, 2009

Primary Completion

August 1, 2009

Study Completion

May 1, 2018

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

CH(1)