Sleep Restriction Therapy + Armodafinil for Insomnia Disorder

Phase 1

Completed

• Conditions: Insomnia Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12614001293651
• Lead Sponsor: Woolcock Institute of Medical Research, Sydney University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-11
• Study Completion: 2019-05-31
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1.Males & Females aged 18-70 years.
2.Able to give informed written consent.
3.Literacy in English.
4.Symptoms of Insomnia Disorder as diagnosed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for Insomnia Disorder specifically: Difficulty initiating or maintaining sleep or waking up too early for at least 3 nights per week, for at least 3 months, with adequate opportunity and circumstances for sleep and at least one daytime impairment related to the sleep difficulty. Assessed by telephone screening interview.
5.Insomnia Severity Index scale scores of 15 or more.
6.Never previously treated with CBT-I or armodafinil.
7.At least one month hypnotic free and willing to not take hypnotics for the duration of the trial.

Exclusion Criteria

1.Pregnancy or lactation.
2.Patients with moderate-severe skin allergies and/or eczema.
3.Shift workers who rotate to night shift.
4.Drug addiction or alcoholism.
5.Severe unstable Psychiatric disorders.
6.Sleep disorders (other than untreated insomnia) and an apnea-hypopnea index >15 if suspected for sleep apnea.
7.Severe cognitive impairment that does not allow patients to consent or follow treatment instructions.
8.Recent time-zone travel (within last 1 month).
9.Conditions that contraindicate armodafinil or sleep restriction therapy in the opinion of the Principal Investigator (Medical Practitioner).
9. (a) Liver function tests exceeding the 95% confidence limits of normal which in the opinion of the medical PI contraindicate armodafinil.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insomnia severity measured self-report capture of the Insomnia Severity Index at 12 weeks from the start of sleep restriction therapy, by either online or paper version.[We are measuring this at screening (baseline), weeks 1, 2, 3, 4, 6 & 12 from treatment start. For the statistical model we are using all data. Week 12 of treatment is the primary endpoint.]