Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome; Obesity
• Intervention / Treatment: Device: Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Absence of sleep apnea syndrome; Pain perception tests	Device: 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.
Experimental: Presence of sleep apnea syndrome; Pain perception tests and for severe sleep apnea syndrome, treatment by positive airway pressure (PPC) ventilation	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scales of pain	sensibility, detection, tolerance	at day 1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Magalie MIOLANNE-DEBOUIT, PH, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2010
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: September 4, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 11, 2017

Study Record Updates

• Last Update Posted (Actual): September 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Obesity; Obstructive sleep apnea syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: CHU-348; 2008-A01045-50 (Other Identifier: 2008-A01045-50)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No