N/A
Completed N=56
Study of Pain Processing in Subjects Suffering From Obstructive Sleep Apnea
Sleep Apnea, Obstructive
Source: ClinicalTrials.gov NCT00672737 ↗
Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Experimental Cold-induced Pain - IGFBP-1 — 0.0025 [sec/(mcg/mL)] /pg/mL — p=<0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Experimental Cold-induced Pain - IGFBP-1 |
0.0025 | <0.05 sig |
| PRIMARY Experimental Heat-induced Pain - IGFBP-1 |
-0.0001 | <0.05 sig |
| PRIMARY Experimental Cold-induced Pain - SaO2 |
-0.9694 | — |
| PRIMARY Experimental Heat-induced Pain - SaO2 |
-0.0172 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00672737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.