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| Name | Class |
|---|---|
| Agence Régionale de Santé Rhône-Alpes | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Effective CPAP | Experimental | Continuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks. |
|
| Sub-therapeutic CPAP | Sham Comparator | Sub-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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Effective CPAP | Device | Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change from baseline of double support time and percentage at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Continuous Positive Airway Pressure Observance at 8 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard WUYAM, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de rééducation, Hôpital Sud, CHU de GRENOBLE | Échirolles | Isère | 38130 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24999279 | Background | 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. | |
| 25150985 | Background |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| Sub-therapeutic CPAP | Device | Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks |
|
|
To assess gait stability, mean double support time will be assess and its coefficient of variation calculate. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 8 weeks |
| Celle 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. |
| 33927278 | Derived | Baillieul 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. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012138 |
| Respiratory Therapy |