Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Phase 4TerminatedNCT00626210

VA Palo Alto Health Care System2 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Insomnia Sleep Initiation and Maintenance Disorders Alzheimer Disease

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Nocturnal Sleep Length at 1 Month

Time frame: 1 month

Secondary Outcomes

Improvement of Daytime Alertness and Quality of Life.

Time frame: ~1 month