Obstructive Sleep ApneaOSA_GaitNCT02061046
To Study the Impact of CPAP on Gait Parameters in OSA Patients
An observational study of Obstructive Sleep Apnea, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP therapy
- Type of treatment
- Medical device
- How many people
- 35 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2009to May 2018
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: OSA patients without any prior treatment
Who may be able to join
- OSA patients newly diagnosed
Who cannot join
- acute medical illness in the past months
- neurological and psychiatric diseases
- orthopaedic, rheumatologic or any sensory conditions affecting normal walking
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
About this study
Official title: Impact of the CPAP on Gait in OSA Patients
To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome.
Read the detailed description
To study the impact of CPAP therapy on gait velocity and temproral gait in patients with obstructive sleep apnea syndrome using the SMTEC system. Patients will be assessed before and 8 weeks after CPAP therapy.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP therapy
- Keywords
- Gait, Dual task
- 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.
CPAP therapyDevice
8 weeks of CPAP therapy
| Study group | Role | What they receive |
|---|---|---|
| On CPAP therapy | OSA patients assessed before and after 8 weeks of CPAP therapy Receives: Device: CPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters: gait velocity [m/s]
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startAug 2009
- Primary completionAug 2009
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilles Allali, University Hospital, Geneva
- Investigators
- Gilles Allali, MD/PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061046
- Sponsor's protocol ID
- PRD 10-II-7
- Acronym
- OSA_Gait
- Status last verified
- Nov 2015
- First submitted
- 7 Feb 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the CPAP on Gait in OSA Patients
- ClinicalTrials.gov ID
- NCT02061046
- Acronym / sponsor ID
- OSA_Gait / PRD 10-II-7
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Gait, Dual task
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- May 2018 (estimated)
- First posted
- 12 Feb 2014 (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.
To study the impact of CPAP therapy on gait in patients with obstructive sleep apnea syndrome.
Detailed description
To study the impact of CPAP therapy on gait velocity and temproral gait in patients with obstructive sleep apnea syndrome using the SMTEC system. Patients will be assessed before and 8 weeks after CPAP therapy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| On CPAP therapy | – | Device: CPAP therapyOSA patients assessed before and after 8 weeks of CPAP therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- OSA patients without any prior treatment
Key inclusion criteria (1 listed)
- OSA patients newly diagnosed
Key exclusion criteria (3 listed)
- acute medical illness in the past months
- neurological and psychiatric diseases
- orthopaedic, rheumatologic or any sensory conditions affecting normal walking
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 |
|---|---|---|
| CPAP therapy8 weeks of CPAP therapy | Device | On CPAP therapy |
Primary outcome
Gait parameters: gait velocity [m/s]
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Gilles Allali, MD/PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by University Hospital, Geneva at 1 site in Switzerland.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. 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 Switzerland. 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. 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?
Results are not available in the source record.
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?
Gait parameters: gait velocity [m/s] (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2015.