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
| Type | Name | Description |
|---|---|---|
| DEVICE | Effective CPAP | Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks |
| DEVICE | Sub-therapeutic CPAP | Sub-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.