ObesityNCT03277963
Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
A study testing Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®) in people with Obesity and Obstructive Sleep Apnea Syndrome, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand, the SAOS could generate pain perception disorders in a population already affected by the mechanical weight constraints, generating… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Obstructive Sleep Apnea Syndrome
- What is being tested?
- Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2010to 1 Aug 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age,
- male or female,
- obesity defined by a body mass index (BMI = weight in kg / height in m²) ≥ 30,
- free from acute or chronic painful pathology,
- free from any chronic analgesic treatment,
- free from any psychotropic treatment by benzodiazepine and / or tricyclic antidepressant,
Show all 15Show fewer
- presence of obstructive sleep apnea syndrome (with apnea-hypopnea index (IAH) 10 per hour of sleep) among 60 patients,
- absence of obstructive sleep apnea syndrome (IAH <10 per hour of sleep) among 60 patients,
- person who signed the information and consent form,
- patients who have been screened for sleep apnea syndrome by Somnochek® negative (AHI <10 / h) in the last 6 months, provided that their weight is the same or lower at the time of inclusion,
- Somnochek® sleep apnea syndrome screening positive and severe for hospitalization (IAH> 30 / h) in the last 3 months, provided that their weight is the same or higher at the time of inclusion.
- In addition, the 23 patients in the subgroup with severe OSA must meet the following criteria:
- presence of obstructive sleep apnea syndrome (with apnea-hypopnea index (IAH) 30 per hour of sleep) among 23 patients,
- acceptance of treatment with PCC,
- availability to come to the CHU for the control of pain threshold perception tests one month after the introduction of PPC treatment.
Who cannot join
- difficulties in understanding and speaking French,
- an alcohol abuse or dependence (DSM-IV),
- an abuse or dependence on illicit drugs (DSM-IV),
- an acute or chronic inflammatory pathology,
- a neuro-muscular pathology,
- clinical signs of right heart failure,
Show all 13Show fewer
- an analgesic treatment,
- treatment with benzodiazepines and / or tricyclic antidepressants, a β-blocking treatment,
- Central sleep apnea,
- person who is absent from another study or who has received more than 4500 euros in the year following his participation in clinical studies,
- pregnant or nursing women,
- person under tutelage or deprived of his rights,
- refusal to sign the information and consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand, the SAOS could generate pain perception disorders in a population already affected by the mechanical weight constraints, generating potentially painful complications, and on the other hand, the improvement of sleep provided by continuous positive airway pressure (PPC) ventilation could "normalize" the pain perception thresholds. It was shown an early rebound effect after treatment on increasing pain threshold in the healthy subject. We want to check it among obese patients with OSA in early and mid-term.
Read the detailed description
In this controlled study, patients of both sexes over 18 years of age who are obese with a body mass index (BMI) of 30 will be included. They will benefit from a polygraphy to confirm or invalidate the presence of an obstructive sleep apnea syndrome (defined by an apnea-hypopnea index to 10). Patients will be tested for mechanical and electrical pain within one week of diagnosis. Among these patients, those with severe SAOS (IAH 30) warrant treatment with continuous positive airway pressure (usual procedure). They will be hospitalized for the implementation of this treatment (usual procedure) and subjected to mechanical and electrical pain tests on the second day after the treatment is put in place.
One month after the start of treatment, they will benefit from an ambulatory polygraph test (usual procedure) as well as mechanical and electrical pain tests.
- Conditions
- Obesity, Obstructive Sleep Apnea Syndrome
- Being tested
- Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)
- Keywords
- Obesity, Obstructive sleep apnea syndrome
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)Device
From a basal level causing no particular sensation, the mechanical or electrical stimulus is applied with a constant increasing rate of progression.
| Study group | Role | What they receive |
|---|---|---|
| Absence of sleep apnea syndrome | Active comparator | Pain perception tests Receives: Device: Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®) |
| Presence of sleep apnea syndrome | Experimental | Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation Receives: Device: Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
scales of pain
sensibility, detection, tolerance
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start4 Feb 2010
- Primary completion1 Feb 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magalie MIOLANNE-DEBOUIT, PH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277963
- Sponsor's protocol ID
- CHU-348
- Other IDs
- 2008-A01045-50
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 13 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
- ClinicalTrials.gov ID
- NCT03277963
- Acronym / sponsor ID
- CHU-348
- Conditions
- Obesity, Obstructive Sleep Apnea Syndrome
- Keywords
- Obesity, Obstructive sleep apnea syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Feb 2010 (actual)
- Primary completion
- 1 Feb 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 11 Sep 2017 (actual)
- 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.
Obstructive sleep apnea syndrome (SAOS), very commonly associated with obesity, induces major disturbances in sleep architecture. The hypotheses in this work are twofold: on the one hand, the SAOS could generate pain perception disorders in a population already affected by the mechanical weight constraints, generating potentially painful complications, and on the other hand, the improvement of sleep provided by continuous positive airway pressure (PPC) ventilation could "normalize" the pain perception thresholds. It was shown an early rebound effect after treatment on increasing pain threshold in the healthy subject. We want to check it among obese patients with OSA in early and mid-term.
Detailed description
In this controlled study, patients of both sexes over 18 years of age who are obese with a body mass index (BMI) of 30 will be included. They will benefit from a polygraphy to confirm or invalidate the presence of an obstructive sleep apnea syndrome (defined by an apnea-hypopnea index to 10). Patients will be tested for mechanical and electrical pain within one week of diagnosis. Among these patients, those with severe SAOS (IAH 30) warrant treatment with continuous positive airway pressure (usual procedure). They will be hospitalized for the implementation of this treatment (usual procedure) and subjected to mechanical and electrical pain tests on the second day after the treatment is put in place.
One month after the start of treatment, they will benefit from an ambulatory polygraph test (usual procedure) as well as mechanical and electrical pain tests.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absence of sleep apnea syndrome | Active comparator | Device: Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)Pain perception tests |
| Presence of sleep apnea syndrome | Experimental | Device: Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients over 18 years of age,
- male or female,
- obesity defined by a body mass index (BMI = weight in kg / height in m²) ≥ 30,
- free from acute or chronic painful pathology,
- free from any chronic analgesic treatment,
Key exclusion criteria (13 listed)
- difficulties in understanding and speaking French,
- an alcohol abuse or dependence (DSM-IV),
- an abuse or dependence on illicit drugs (DSM-IV),
- an acute or chronic inflammatory pathology,
- a neuro-muscular pathology,
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 |
|---|---|---|
| Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)From a basal level causing no particular sensation, the mechanical or electrical stimulus is applied with a constant increasing rate of progression. | Device | Absence of sleep apnea syndrome, Presence of sleep apnea syndrome |
Primary outcome
scales of pain
Time frame: at day 1
sensibility, detection, tolerance
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 13 Sep 2017.
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.
Magalie MIOLANNE-DEBOUIT, PH principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®) in people with Obesity and Obstructive Sleep Apnea Syndrome, run by University Hospital, Clermont-Ferrand 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 15 inclusion and 13 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 13 Sep 2017. 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?
scales of pain (time frame: at day 1). 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 13 Sep 2017.