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

Obstructive Sleep Apnea Syndrome Clinical Trial

— CIH-Gait  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345694
• Other study ID #: 2014-A01523-44
• Status: Completed
• Phase: N/A
• Start date: February 3, 2015
• Est. completion date: December 7, 2018

Study information

• Verified date: March 2020
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 7, 2018
• Est. primary completion date: November 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Device:
• Effective CPAP
Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
• Sub-therapeutic CPAP
Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks

Locations

Country	Name	City	State
France	Institut de rééducation, Hôpital Sud, CHU de GRENOBLE	Echirolles	Isère

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Agence Régionale de Santé Rhône-Alpes

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Celle S, Annweiler C, Camicioli R, Barthélémy 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in Dual Task Cost (DTC) at 8 weeks	Dual Task Cost = [(Dual Task % correct - Single Task % correct) x 100 / Single Task % correct]	Baseline and 8 weeks
Other	Continuous Positive Airway Pressure Observance at 8 weeks		8 weeks
Primary	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	Change from baseline of single support time and percentage at 8 weeks	To assess gait stability, mean single support time will be assess under single (walking alone) and dual task condition (walking while performing a cognitive task) and its coefficient of variation calculate.	Baseline and 8 weeks
Secondary	Change from baseline of double support time and percentage at 8 weeks	To assess gait stability, mean double support time will be assess and its coefficient of variation calculate.	Baseline and 8 weeks
Secondary	Change from baseline of gait speed at 8 weeks		Baseline and 8 weeks
Secondary	Change from baseline of step length at 8 weeks		Baseline and 8 weeks
Secondary	Change from baseline of step width at 8 weeks		Baseline and 8 weeks
Secondary	Change from baseline of the center-of-pressure area at 8 weeks	Studying gait implies posture assessment as the link between gait stability and an efficient postural control is tenuous.	Baseline and 8 weeks
Secondary	Change from baseline of the center-of-pressure length at 8 weeks	Combined with center-of-pressure (CoP) area, the length (path of CoP) of CoP permits efficient measurement of CoP spatial variability.	Baseline and 8 weeks
Secondary	Change from baseline of the center-of-pressure mean speed at 8 weeks	The mean speed represents a good index of the amount of neuromuscular activity required to regulate postural control.	Baseline and 8 weeks
Secondary	Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks	The oxyhaemoglobin concentration will be recorded during an treadmill 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 placed in front of the patient.; We use a fNIRS (Near Infrared Spectroscopy) device, disposed bilaterally opposite to prefrontal cortices to assess the change of oxyhemoglobin concentration over different motor and cognitive tasks.	Baseline and 8 weeks
Secondary	Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks	The deoxyhemoglobin concentration will be recorded as oxyhaemoglobin concentration.	Baseline and 8 weeks
Secondary	Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks	The total haemoglobin concentration will be recorded as oxyhaemoglobin concentration.	Baseline and 8 weeks