Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
Primary Purpose
Obesity, Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)
Sponsored by
![University Hospital, Clermont-Ferrand](https://trials-media.s3.amazonaws.com/orgs/university-hospital-clermont-ferrand.jpeg)
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Obstructive sleep apnea syndrome
Eligibility Criteria
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Absence of sleep apnea syndrome
Presence of sleep apnea syndrome
Arm Description
Pain perception tests
Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation
Outcomes
Primary Outcome Measures
scales of pain
sensibility, detection, tolerance
Secondary Outcome Measures
Full Information
NCT ID
NCT03277963
First Posted
September 4, 2017
Last Updated
September 12, 2017
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT03277963
Brief Title
Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
Official Title
Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 4, 2010 (Actual)
Primary Completion Date
February 1, 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Obstructive Sleep Apnea Syndrome
Keywords
Obesity, Obstructive sleep apnea syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Absence of sleep apnea syndrome
Arm Type
Active Comparator
Arm Description
Pain perception tests
Arm Title
Presence of sleep apnea syndrome
Arm Type
Experimental
Arm Description
Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation
Intervention Type
Device
Intervention Name(s)
Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)
Intervention Description
From a basal level causing no particular sensation, the mechanical or electrical stimulus is applied with a constant increasing rate of progression.
Primary Outcome Measure Information:
Title
scales of pain
Description
sensibility, detection, tolerance
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
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.
Exclusion Criteria:
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,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magalie MIOLANNE-DEBOUIT, PH
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
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Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
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