Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Phase 4

Terminated

• Conditions: Insomnia; Alzheimer Disease; Sleep Initiation and Maintenance Disorders
• Interventions: Drug: modafinil

• Registration Number: NCT00626210
• Lead Sponsor: VA Palo Alto Health Care System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Primary Completion: 2011-04
• Study Completion: 2012-10
• Results First Submitted: 2014-06-12
• Results First Submitted QC: 2014-10-28
• Results First Posted: 2014-10-30
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-24
• Last Update Posted: 2019-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Modafinil	modafinil	-

Primary Outcome Measures

Name	Time	Method
Nocturnal Sleep Length at 1 Month	1 month

Secondary Outcome Measures

Name	Time	Method
Improvement of Daytime Alertness and Quality of Life.	~1 month

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States