Randomised double-blind, placebo-controlled, crossover trial on the effects of modafinil on sleep apnea patients withdrawn from continuous positive airway pressure (cpap) treatment

Conditions

None listed

Williams SC, Marshall NS, Kennerson M, Rogers NL, Liu PY, Grunstein RR.

2010-01-0730 citations

10.1164/rccm.200908-1307oc

Interventions

This randomised double-blind, placebo-controlled study will examine the efficacy of modafinil to counteract possible daytime sleepiness after CPAP withdrawal in long-term CPAP users. Subjects will be given an 'Autoset' CPAP machine to take home to assess their CPAP compliance and subjects will also be given an Actiwatch to assess sleep-wake activity for 7 days. Subjects will then report to the laboratory where they will undergo overnight polysomnographies using CPAP for two nights and then for t

This randomised double-blind, placebo-controlled study will examine the efficacy of modafinil to counteract possible daytime sleepiness after CPAP withdrawal in long-term CPAP users. Subjects will be given an 'Autoset' CPAP machine to take home to assess their CPAP compliance and subjects will also be given an Actiwatch to assess sleep-wake activity for 7 days. Subjects will then report to the laboratory where they will undergo overnight polysomnographies using CPAP for two nights and then for two nights without using CPAP. During the waking hours subjects will complete a variety of neurocognitive tasks and questionniares. After a washout period of 28 days, subjects will repeat the protocol, receiving the other study medication.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

No

Inclusion criteria

Diagnosed obstructive sleep apnea by night polysomnography and having an apnea hypopnea index (AHI or RDI) = 30, treated with Continuous Positive Airway Pressure (CPAP) treatment for at least one year, absence of significant co-morbidities.

Exclusion criteria

Previous CVA, current psychotropic drug use, such as methylphenidate; clomipramine; and, monoamine oxidase inhibitors. In addition, concomitant medications that inhibit or are metabolised by cytochrome p-450 isoenzymes and other hepatic enzymes and daytime blood pressure exceeds >160mmHg/>100mmHg at the baseline visit.

Outcome results