NCT03277963

Perception of Pain During Obstructive Sleep Apnea Syndrome in Obese Patient

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-02-04
• Primary completion: 2017-02-01
• Completion: 2017-08-01
• First posted: 2017-09-11
• Last updated: 2017-09-13

Locations

1 site across 1 country: France