Obstructive Sleep Apnea SyndromeCIH-GaitNCT02345694
Non-automatic Control of Gait and Posture in Obstructive Sleep Apnea Syndrome (CIH-Gait)
A study testing Effective CPAP and Sub-therapeutic CPAP in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Effective CPAP and Sub-therapeutic CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 3 Feb 2015to 7 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 9Show fewer
- Psychotropic treatment intake,
- Alcoholism,
- Member of an at-risk occupation (car, bus, truck drivers...) mandating effective continuous positive airway pressure introduction.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de rééducation, Hôpital Sud, CHU de GRENOBLE
Échirolles, Isère, 38130
About this study
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)
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.
Read the 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
- Obstructive Sleep Apnea Syndrome
- Being tested
- Effective CPAP, Sub-therapeutic CPAP
- Keywords
- Obstructive Sleep Apnea Syndrome, Gait, Posture, Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective CPAPDevice
Also called Continuous positive airway pressure (RESMED S9™ Series)
Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
Sub-therapeutic CPAPDevice
Also called Sham-CPAP (RESMED S9™ Sham-CPAP System)
Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Effective CPAP | Experimental | Continuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks. Receives: Device: Effective CPAP |
| 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. Receives: Device: Sub-therapeutic CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 8 weeks
Secondary outcomes (11)
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.
Measured: Baseline and 8 weeks
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.
Measured: Baseline and 8 weeks
Change from baseline of gait speed at 8 weeks
Measured: Baseline and 8 weeks
Change from baseline of step length at 8 weeks
Measured: Baseline and 8 weeks
Change from baseline of step width at 8 weeks
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start3 Feb 2015
- Primary completion28 Nov 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes
- Responsible party
- Principal investigator, AdministrateurDRC, University Hospital, Grenoble
- Investigators
- Bernard WUYAM, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345694
- Sponsor's protocol ID
- 2014-A01523-44
- Acronym
- CIH-Gait
- Status last verified
- Mar 2020
- First submitted
- 12 Jan 2015
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24999279Celle 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.
PubMed 25150985Baillieul 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.
PubMed 33927278
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02345694
- Acronym / sponsor ID
- CIH-Gait / 2014-A01523-44
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Obstructive Sleep Apnea Syndrome, Gait, Posture, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Agence Régionale de Santé Rhône-Alpes
- Study start
- 3 Feb 2015 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective CPAP | Experimental | Device: Effective CPAPContinuous Positive Airway Pressure (RESMED S9™ Series), all the nights, during 8 weeks. |
| Sub-therapeutic CPAP | Sham comparator | Device: Sub-therapeutic CPAPSub-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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effective CPAPAlso: Continuous positive airway pressure (RESMED S9™ Series)Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks | Device | Effective CPAP |
| Sub-therapeutic CPAPAlso: Sham-CPAP (RESMED S9™ Sham-CPAP System)Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks | Device | Sub-therapeutic CPAP |
Primary outcome
Change from baseline of stride time coefficient of variation at 8 weeks
Time frame: Baseline and 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.
11 secondary outcomes
Change from baseline of single support time and percentage at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of double support time and percentage at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of gait speed at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of step length at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of step width at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of the center-of-pressure area at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of the center-of-pressure length at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of the center-of-pressure mean speed at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of oxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of deoxy-haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Time frame: Baseline and 8 weeks
Change from baseline of total haemoglobin concentration of bilateral prefrontal cortices at 8 weeks
Time frame: Baseline and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 24999279Allali 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.
- Background: PubMed 25150985Celle 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.
- Derived from this study: PubMed 33927278Baillieul 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard WUYAM, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effective CPAP and Sub-therapeutic CPAP in people with Obstructive Sleep Apnea Syndrome, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline of stride time coefficient of variation at 8 weeks (time frame: Baseline and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02345694, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.