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

Primary Purpose

Obstructive Sleep Apnea, Delayed Emergence From Anesthesia

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Modafinil

Placebo

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, General Anesthesia, Modafinil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Sites / Locations

Penn State Hershey Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Intervention

Arm Description

Administered Placebo day of surgery immediately prior to general anesthesia and surgery

Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery

Outcomes

Primary Outcome Measures

Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit

Length of time of above compared between groups

Secondary Outcome Measures

Postanesthesia Quality Recovery Scale Score

Postanesthesia quality recovery scale (PQRS). Component and aggregate scoring on the scale. Measures physiology, nociceptive, emotional activities of daily living cognitive and overall patient perspective. The scale is dimensionless and the aggregate of all individually tested dimensions is scaled from 17-65. A higher value implies improved postanesthesia recovery. Mean difference was assessed in each patient and aggregated thus patients with no difference between pre- and post-operative scores were zeroed (received a zero score if the difference was zero). A negative value was associated with worse outcome.

Full Information

NCT ID

NCT02494102

First Posted

July 1, 2015

Last Updated

June 19, 2019

Sponsor

Milton S. Hershey Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02494102

Brief Title

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

Acronym

ModOSA

Official Title

A Randomized, Double Blind, Placebo Controlled Evaluation of Modafinil vs Placebo for the Treatment of General Anesthesia Related Delayed Emergence in Patients With the Diagnosis of Obstructive Sleep Apnea

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Terminated

Study Start Date

February 2016 (undefined)

Primary Completion Date

April 1, 2018 (Actual)

Study Completion Date

April 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

Detailed Description

This is a randomized, double blind placebo controlled evaluation of modafinil versus placebo for the treatment of general anesthesia related delayed emergence in patients with the diagnosis of obstructive sleep apnea. 124 patients will be recruited and randomized on the day of surgery to receive 200mg modafinil or placebo. After randomization, patients will proceed to the operative suite for surgical procedure under general anesthesia. The primary outcome measured will be post-anesthesia care unit length of stay. Secondary outcomes will include performance on a post-anesthesia recovery scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea, Delayed Emergence From Anesthesia

Keywords

Obstructive Sleep Apnea, General Anesthesia, Modafinil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

double blind randomized placebo controlled trial

Masking

ParticipantInvestigator

Masking Description

Computer generated randomization list, subject, clinical team and research team blinded to intervention

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administered Placebo day of surgery immediately prior to general anesthesia and surgery

Arm Title

Intervention

Arm Type

Active Comparator

Arm Description

Administered Modafinil 200mg day of surgery prior to general anesthesia and surgery

Intervention Type

Drug

Intervention Name(s)

Modafinil

Other Intervention Name(s)

Armodafinil, Provigil

Intervention Description

Atypical Psychomotor stimulant

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Length of Time From Extubation to Discharge From Postanesthesia Recovery Unit

Description

Length of time of above compared between groups

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Postanesthesia Quality Recovery Scale Score

Description

Time Frame

baseline and 6 hours after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zyad J Carr, M.D.

Organizational Affiliation

Milton S. Hershey Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Penn State Hershey Medical Center

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17712350

Citation

Minzenberg MJ, Carter CS. Modafinil: a review of neurochemical actions and effects on cognition. Neuropsychopharmacology. 2008 Jun;33(7):1477-502. doi: 10.1038/sj.npp.1301534. Epub 2007 Aug 22.

Results Reference

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PubMed Identifier

10767651

Citation

Moldofsky H, Broughton RJ, Hill JD. A randomized trial of the long-term, continued efficacy and safety of modafinil in narcolepsy. Sleep Med. 2000 Apr 1;1(2):109-116. doi: 10.1016/s1389-9457(99)00014-3.

Results Reference

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PubMed Identifier

10895398

Citation

Jasinski DR, Kovacevic-Ristanovic R. Evaluation of the abuse liability of modafinil and other drugs for excessive daytime sleepiness associated with narcolepsy. Clin Neuropharmacol. 2000 May-Jun;23(3):149-56. doi: 10.1097/00002826-200005000-00004.

Results Reference

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PubMed Identifier

10757254

Citation

Jasinski DR. An evaluation of the abuse potential of modafinil using methylphenidate as a reference. J Psychopharmacol. 2000 Mar;14(1):53-60. doi: 10.1177/026988110001400107.

Results Reference

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PubMed Identifier

11222668

Citation

Wisor JP, Nishino S, Sora I, Uhl GH, Mignot E, Edgar DM. Dopaminergic role in stimulant-induced wakefulness. J Neurosci. 2001 Mar 1;21(5):1787-94. doi: 10.1523/JNEUROSCI.21-05-01787.2001.

Results Reference

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PubMed Identifier

9097352

Citation

Arnulf I, Homeyer P, Garma L, Whitelaw WA, Derenne JP. Modafinil in obstructive sleep apnea-hypopnea syndrome: a pilot study in 6 patients. Respiration. 1997;64(2):159-61. doi: 10.1159/000196661.

Results Reference

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PubMed Identifier

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Citation

Pack AI, Black JE, Schwartz JR, Matheson JK. Modafinil as adjunct therapy for daytime sleepiness in obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Nov 1;164(9):1675-81. doi: 10.1164/ajrccm.164.9.2103032.

Results Reference

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PubMed Identifier

15041583

Citation

Larijani GE, Goldberg ME, Hojat M, Khaleghi B, Dunn JB, Marr AT. Modafinil improves recovery after general anesthesia. Anesth Analg. 2004 Apr;98(4):976-981. doi: 10.1213/01.ANE.0000108485.29288.B4.

Results Reference

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PubMed Identifier

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Citation

Galvin E, Boesjes H, Hol J, Ubben JF, Klein J, Verbrugge SJ. Modafinil reduces patient-reported tiredness after sedation/analgesia but does not improve patient psychomotor skills. Acta Anaesthesiol Scand. 2010 Feb;54(2):154-61. doi: 10.1111/j.1399-6576.2009.02093.x. Epub 2009 Aug 31.

Results Reference

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

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