Modafinil Treatment for Sleep/Wake Disturbances in Older Adults
| Status: | Terminated |
|---|---|
| Conditions: | Alzheimer Disease, Insomnia Sleep Studies |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 1/31/2018 |
| Start Date: | February 2008 |
| End Date: | October 2012 |
Modafinil, trade named Provigil, is a medication approved by the Food and Drug Administration
for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work
sleep disorder. Each of these problems is characterized by difficulty sleeping at night and
excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this
sleepiness. The idea behind this treatment is that sleepiness that leads to napping during
the day prevents a patient from being tired or sleepy enough to get good sleep at night. This
study is designed to determine if the medication can "reset" participants' sleep/wake rhythm
to a more normal rhythm.
for the treatment of narcolepsy, obstructive sleep apnea/hypopnea syndrome, and shift work
sleep disorder. Each of these problems is characterized by difficulty sleeping at night and
excessive daytime sleepiness. Modafinil is prescribed during the day to counteract this
sleepiness. The idea behind this treatment is that sleepiness that leads to napping during
the day prevents a patient from being tired or sleepy enough to get good sleep at night. This
study is designed to determine if the medication can "reset" participants' sleep/wake rhythm
to a more normal rhythm.
Inclusion Criteria:
- A clinical diagnosis of Alzheimer's disease or Mild Cognitive Impairment
- Subjective complaint of sleep disruption, unsatisfactory sleep, early morning
awakening, early bedtime, or excessive daytime sleepiness. Such complaint can be made
by either the potential participant or by the caregiver.
Exclusion Criteria:
- Participation in any other clinical drug trial
- Liver failure
- Believed by the investigator to be unwilling or unable to follow the protocol
- Active liver or coronary disease
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