Status:
COMPLETED
Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Obesity
Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 cou...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 4 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT03277963
Start Date
February 4 2010
End Date
August 1 2017
Last Update
September 13 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003