Clinical Trials Directory

Trials / Completed

CompletedNCT02345694

Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)

Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome : a Randomised Controlled Trial of Continuous Positive Airway Pressure Effectiveness (CIH - Gait)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
University Hospital, Grenoble · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

Summary

The purpose of this randomised controlled study is to determine the impact of continuous positive airway pressure (CPAP) versus sub-therapeutic CPAP (placebo) on the control of gait upon severe sleep apnea patients, based on stride time variability.

Detailed description

As severe sleep apnea patients exhibit gait abnormalities, this is the first randomised controlled trial to our knowledge to assess the impact of CPAP upon gait and postural control in severe sleep apnea patients. Based on a dual-task paradigm, posture and gait analysis will be perform before and after 8 week of intervention. Beside gait parameters, the cerebral metabolism will be assessed using a Near Infrared Spectroscopy (fNIRS) device during normal walking and during walking while dual-tasking, using a visual and a verbal task.

Conditions

Interventions

TypeNameDescription
DEVICEEffective CPAPEffective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
DEVICESub-therapeutic CPAPSub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks

Timeline

Start date
2015-02-03
Primary completion
2018-11-28
Completion
2018-12-07
First posted
2015-01-26
Last updated
2020-03-18

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02345694. Inclusion in this directory is not an endorsement.