Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea
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|
|Start date||February 2008|
|End date||August 2010|
|Trial size||50 participants|
|Trial identifier||NCT00672737, 10374, SU-01222008-985|
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.
|Endpoint classification||pharmacodynamics study|
|Intervention model||single group assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
|Primary purpose||supportive care|
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
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.
|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.|
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