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Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00672737
First received: May 2, 2008
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Sleep Apnea, Obstructive
 Drug: Remifentanil
Procedure: Ice water used to assess cold pain threshold and tolerance
Device: TSAII Neuroanalyzer (Medoc Advanced Medical Systems, Durham, NC), Used to assess heat pain threshold and tolerance
 Phase 1

Study Type: Interventional
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
Official Title: Experimental Pain Processing and Autonomic Function in Subjects Suffering From Obstructive Sleep Apnea

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672737

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Anthony Doufas Stanford University
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anthony Doufas, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00672737     History of Changes
Other Study ID Numbers: SU-01222008-985, 10374
Study First Received: May 2, 2008
Last Updated: May 7, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Stress, Psychological
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Behavioral Symptoms
Remifentanil
 Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on May 16, 2013