Clinical trial NCT00672737: Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea
Official title: Experimental Pain Processing and Autonomic Function in Subjects Suffering From Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males at risk for obstructive sleep apnea (OSA). We invited male volunteers (18 55 years old) with a history of habitual snoring and/or a formal diagnosis of OSA to participate in a study evaluating sleep and experimental pain processing.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Experimental Cold-induced Pain - IGFBP-1
timeFrame: 2 to 3 weeks
measure: Experimental Heat-induced Pain - IGFBP-1
timeFrame: 2 to 3 weeks
measure: Experimental Cold-induced Pain - SaO2
timeFrame: 2 to 3 weeks
measure: Experimental Heat-induced Pain - SaO2
timeFrame: 2 to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Anthony Doufas
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doufas AG, Tian L, Padrez KA, Suwanprathes P, Cardell JA, Maecker HT, Panousis P. Experimental pain and opioid analgesia in volunteers at high risk for obstructive sleep apnea. PLoS One. 2013;8(1):e54807. doi: 10.1371/journal.pone.0054807. Epub 2013 Jan 29.