Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)
CIH-Gait
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 12, 2015
CompletedFirst Posted
Study publicly available on registry
January 26, 2015
CompletedStudy Start
First participant enrolled
February 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2018
CompletedMarch 18, 2020
March 1, 2020
3.8 years
January 12, 2015
March 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of stride time coefficient of variation at 8 weeks
The stride time will be recorded during an overground walking test, under single (walking alone) and dual-task (walking while performing a cognitive task) condition. The cognitive task used in our protocol is an electronic Stroop test, displayed on a screen at the end of the 10 meters walkway. The coefficient of variation allows us to estimate stride time variability, known to be the reflect of gait control efficiency when it exhibits low values.
Baseline and 8 weeks
Secondary Outcomes (11)
Change from baseline of single support time and percentage at 8 weeks
Baseline and 8 weeks
Change from baseline of double support time and percentage at 8 weeks
Baseline and 8 weeks
Change from baseline of gait speed at 8 weeks
Baseline and 8 weeks
Change from baseline of step length at 8 weeks
Baseline and 8 weeks
Change from baseline of step width at 8 weeks
Baseline and 8 weeks
- +6 more secondary outcomes
Other Outcomes (2)
Change from baseline in Dual Task Cost (DTC) at 8 weeks
Baseline and 8 weeks
Continuous Positive Airway Pressure Observance at 8 weeks
8 weeks
Study Arms (2)
Effective CPAP
EXPERIMENTALContinuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks.
Sub-therapeutic CPAP
SHAM COMPARATORSub-therapeutic Continuous Positive Airway Pressure (RESMED S9™ Sham-Continuous Positive Airway Pressure System), validated placebo of Continuous Positive Airway Pressure, all the nights, during 8 weeks.
Interventions
Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks
Eligibility Criteria
You may qualify if:
- Normally weighted or over-weighted patients (BMI \< 30 kilograms/m²)
- Newly diagnosed Obstructive Sleep Apnea Syndrome (OSAS) (i.e. no previous treatment)
- Severe OSAS as defined by the American Academy of Sleep Medicine (AHI ≥ 30)
- To speak and understand french
- To be affiliated to social welfare
You may not qualify if:
- Age criteria : \<18 year old and \>70 year old
- Obesity (BMI ≥ 30 kilograms/m²)
- Pathological conditions thought to be responsible of gait unsteadiness and postural sway or requiring an walking device : nervous system disease (Parkinson disease, chronic stroke), cerebellum syndrome, vestibular syndrome, orthopaedic and rheumatic diseases,
- Lower limb sensitivity impairment,
- Cognitive disorder (Folstein test score \< 24),
- Ophthalmology disorder : uncorrected refractive disorder, disturbance of color vision,
- Psychotropic treatment intake,
- Alcoholism,
- Member of an at-risk occupation (car, bus, truck drivers...) mandating effective continuous positive airway pressure introduction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de rééducation, Hôpital Sud, CHU de GRENOBLE
Échirolles, Isère, 38130, France
Related Publications (3)
Allali G, Perrig S, Cleusix M, Herrmann FR, Adler D, Gex G, Armand S, Janssens JP, Pepin JL, Assal F. Gait abnormalities in obstructive sleep apnea and impact of continuous positive airway pressure. Respir Physiol Neurobiol. 2014 Sep 15;201:31-3. doi: 10.1016/j.resp.2014.06.012. Epub 2014 Jul 4.
PMID: 24999279BACKGROUNDCelle S, Annweiler C, Camicioli R, Barthelemy JC, Roche F, Beauchet O. Sleep-related breathing disorders and gait variability: a cross-sectional preliminary study. BMC Pulm Med. 2014 Aug 23;14:140. doi: 10.1186/1471-2466-14-140.
PMID: 25150985BACKGROUNDBaillieul S, Wuyam B, Perennou D, Tamisier R, Bailly S, Benmerad M, Piscicelli C, Le Roux-Mallouf T, Verges S, Pepin JL. A randomized sham-controlled trial on the effect of continuous positive airway pressure treatment on gait control in severe obstructive sleep apnea patients. Sci Rep. 2021 Apr 29;11(1):9329. doi: 10.1038/s41598-021-88642-5.
PMID: 33927278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bernard WUYAM, MD, PhD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Directeur de la recherche clinique
Study Record Dates
First Submitted
January 12, 2015
First Posted
January 26, 2015
Study Start
February 3, 2015
Primary Completion
November 28, 2018
Study Completion
December 7, 2018
Last Updated
March 18, 2020
Record last verified: 2020-03