ObesityOBAIRWAYNCT02832609
Mechanisms of Orthopnea in Stable Obese Patients
A study testing Supine in people with Obesity, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Supine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Oct 2013
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obese (BMI ≥ 30)
- stable condition
- 20 < Age < 60 years
Who cannot join
- other respiratory disorder (COPD)
- left cardiac insufficiency
Trial locations and contacts
1 site in 1 country.
France1 site
Hospices civils de lyon, Hôpital de la Croix-Rousse - Réanimation, Surveillance Continue Médicales et Assistance Respiratoire
Lyon, 69004
About this study
The purpose of this study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position.
In stable obese subjects, in sitting and supine positions, the investigators measured Borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase III, and opening capacity.
Orthopnea was defined as any increase in the Borg score in the supine position from its value in the sitting position
- Conditions
- Obesity
- Being tested
- Supine
- Keywords
- closing volume, expiratory flow limitation, obesity, orthopnea
- Medical subject headings
- Obesity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SupineOther
measurements after 30 minutes in complete supine position
| Study group | Role | What they receive |
|---|---|---|
| sitting position | No intervention | measurement in the sitting position |
| supine position | Active comparator | measurement in the sitting position Receives: Other: Supine |
What is being measured
The primary outcome is the main question the study is designed to answer.
closing volume by nitrogen washout method
Measured: 30 minutes after changing position (hour 2)
Secondary outcomes (2)
static lung volumes by plethysmography
static lung volumes are composed of vital capacity, FEV1, inspiratory capacity, and reserve expiratory volume and are measured by plethysmography
Measured: 30 minutes after changing position (hour 2)
expiratory flow limitation by NEP test
NEP test
Measured: 30 minutes after changing position (hour 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2016 (estimated)
- Study startMar 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude Guérin, Prof, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02832609
- Sponsor's protocol ID
- 2009-574
- Acronym
- OBAIRWAY
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2016
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Perino E, Nesme P, Germain M, Guerin C. Mechanisms of Orthopnea in Stable Obese Subjects. Respir Care. 2016 Aug;61(8):1015-22. doi: 10.4187/respcare.04146. Epub 2016 Apr 5.
PubMed 27048626
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Orthopnea in Stable Obese Patients
- ClinicalTrials.gov ID
- NCT02832609
- Acronym / sponsor ID
- OBAIRWAY / 2009-574
- Conditions
- Obesity
- Keywords
- closing volume, expiratory flow limitation, obesity, orthopnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 14 Jul 2016 (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 study is to study the role of closing volume as a determinant of orthopnea in stable obese subjects. The investigators hypothesized that: (1) increase in closing volume in supine position would be greater in orthopneic than in non-orthopneic subjects, and (2) the relationship of change in closing volume to change in dyspnea with position would be dependent on expiratory flow limitation in the sitting position.
In stable obese subjects, in sitting and supine positions, the investigators measured Borg dyspnea score, static lung volumes, expiratory flow limitation, and single-breath nitrogen expiration test, from which the investigators determined closing volume and closing capacity, slope of phase III, and opening capacity.
Orthopnea was defined as any increase in the Borg score in the supine position from its value in the sitting position
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sitting position | No intervention | –measurement in the sitting position |
| supine position | Active comparator | Other: Supinemeasurement in the sitting position |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- obese (BMI ≥ 30)
- stable condition
- 20 < Age < 60 years
Key exclusion criteria (2 listed)
- other respiratory disorder (COPD)
- left cardiac insufficiency
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 |
|---|---|---|
| Supinemeasurements after 30 minutes in complete supine position | Other | supine position |
Primary outcome
closing volume by nitrogen washout method
Time frame: 30 minutes after changing position (hour 2)
2 secondary outcomes
static lung volumes by plethysmography
Time frame: 30 minutes after changing position (hour 2)
expiratory flow limitation by NEP test
Time frame: 30 minutes after changing position (hour 2)
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 28 May 2019.
- Results publication: PubMed 27048626Perino E, Nesme P, Germain M, Guerin C. Mechanisms of Orthopnea in Stable Obese Subjects. Respir Care. 2016 Aug;61(8):1015-22. doi: 10.4187/respcare.04146. Epub 2016 Apr 5.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
Claude Guérin, Prof principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine in people with Obesity, run by Hospices Civils de Lyon 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 3 inclusion and 2 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 28 May 2019. 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. 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?
closing volume by nitrogen washout method (time frame: 30 minutes after changing position (hour 2)). 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 NCT02832609, which also lists 1 linked publication.
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 28 May 2019.