Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Obstructive Sleep Apnea, Delayed Emergence From Anesthesia

In brief

The purpose of this study is to determine whether modafinil use in patients with obstructive sleep apnea will improve postoperative delayed emergence after general anesthesia.

Key facts

Study ID

NCT02494102

Run by

Milton S. Hershey Medical Center

People needed

105

Starts

2016-02-01

Expected to finish

2018-04-01

Last updated by the study team

2019-06-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years or older
• Meets diagnostic criteria for obstructive sleep apnea
• Willing and able to comply with study procedures
• Willing and able to provide informed consent
• If female, not pregnant or lactating and willing to use an acceptable method of barrier birth control (e.g. condoms) for one month after surgery and discontinuation of study medication (modafinil may reduce the effectiveness of steroidal contraception for one month after discontinuation)

You may not qualify if…

• Have a medical condition that, in the study physician's judgment, may interfere with safe participation (active cardiac conditions such as angina, recent myocardial infarction w/in 6 months, severe renal or liver disease, unstable diabetes, or elevated liver enzymes greater than twice normal).
• Have a current neurological disorder (e.g. organic brain disease, dementia) or major psychiatric condition that would impair the collection of data (schizophrenia, bipolar illness).
• Currently on prescription medication that is known to interact with the study drug. (ethinylestradiol and triazolam).
• Have current dependence on cocaine, methamphetamine, alcohol or benzodiazepines (DSM-IV criteria).
• Have a history of severe valvular heart disease, severe left ventricular hypertrophy, cardiac arrhythmias, angina, cardiac syncope, or pre-syncope or myocardial infarction <6 months.
• Have a history of uncontrolled or poorly controlled essential hypertension, or a heart rate greater than 70% of the maximum heart rate expected for their age (Formula: 0.70(220 - age).
• Any condition, in the opinion of the principal investigators that would compromise patient safety.
• A documented history of sensitivity to modafinil.
• Current Modafinil use for daytime somnolence associated with obstructive sleep apnea.

Where it is running

• Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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