NCT00672737

Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea

Experimental Pain Processing and Autonomic Function in Subjects Suffering From Obstructive Sleep Apnea

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 56 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DRUG	Remifentanil	Remifentanil was administered as a computer-controlled infusion, targeting two different effect site concentrations, 1 and 2 mcg/mL, in randomized order.
PROCEDURE	Cold pain threshold and tolerance	Ice water was used to assess cold-related pain threshold and tolerance, defined as the time that the volunteers could keep their hands in the water before they started feeling pain or this feeling becomes unbearable, for threshold and tolerance, respectively.
DEVICE	Heat pain threshold and tolerance	TSAII Neuroanalyzer (Medoc Advanced Medical Systems, Durham, NC), was used to assess the heat-related pain and tolerance of the volunteers defined as the respective temperatures where they started feeling as painful or unbearable.
PROCEDURE	Polysomnography	All volunteers underwent a polysomnography study at home or at Stanford Sleep Center, approximately one week before their experimental pain assessment in the laboratory

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2008-05-06
• Last updated: 2017-08-07
• Results posted: 2017-08-07

Locations

1 site across 1 country: United States