Overview

This trial is active, not recruiting.

Condition sleep apnea, obstructive
Treatments remifentanil, ice water used to assess cold pain threshold and tolerance, tsaii neuroanalyzer (medoc advanced medical systems, durham, nc), used to assess heat pain threshold and tolerance
Phase phase 1
Sponsor Stanford University
Start date February 2008
End date August 2010
Trial size 50 participants
Trial identifier NCT00672737, 10374, SU-01222008-985

Summary

We would like to test the effect of opioid medication on pain sensitivity in subjects who have been diagnosed with a sleep disorder called Obstructive Sleep Apnea (OSA) compared to other subjects without OSA. Patients with OSA may have an altered sensitivity to the sedative, analgesic, and respiratory depressant effects of opioids.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification pharmacodynamics study
Intervention model single group assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care

Primary Outcomes

Measure
The effect of OSA phenotype on experimental pain processing and the potency of remifentanil for analgesia.
time frame: 2 to 3 weeks after sleep study confirmation of OSA

Eligibility Criteria

Male participants from 18 years up to 55 years old.

Inclusion Criteria:1. Male 2 .18 - 55 years of age 3. Body mass index (BMI) lower or equal to 30 kg/m2 4. Absence of severe systemic disease that results in functional limitations (i.e. poorly controlled hypertension, angina pectoris, prior myocardial infarction, pulmonary disease that limits activity) 5.Subjects must be able to comprehend spoken and written English Exclusion Criteria:1. Major psychiatric, neurological, or neuromuscular disorder 2. Known diabetes mellitus or thyroid disease 3. Allergy to study medication (remifentanil) 4. History of addiction 5. Alcohol consumption which exceeds 2 drinks per day and /or drug abuse. 6. Chronic or acute use of opioids, or other medications affecting the CNS.

Additional Information

Official title Experimental Pain Processing and Autonomic Function in Subjects Suffering From Obstructive Sleep Apnea
Principal investigator Anthony Doufas
Description The purpose of the study is to test the hypothesis that patients who suffer from moderate-to-severe OSA have increased pain thresholds and are more sensitive to the analgesic effects of opioids compared to patients with normal sleep-related breathing physiology. We will evaluate the effect of remifentanil, a short acting mu-opioid receptor agonist, on pain using an experimental heat and cold-induced pain tests, and compare it between volunteers with and without a polysomnography (PSG)-based diagnosis of obstructive sleep apnea.
Trial information was received from ClinicalTrials.gov and was last updated in May 2010.
Information provided to ClinicalTrials.gov by Stanford University.