CompletedPhase 2ACTRN12614001293651

Sleep Restriction Therapy + Armodafinil for Insomnia Disorder

Armodafinil to reduce the sleepiness related side-effects of Sleep Restriction Therapy being used to treat Insomnia Disorder: An open label pilot study compared to historical matched controls.

Sponsor

Woolcock Institute of Medical Research, Sydney University

Enrollment

30 participants

Start Date

Mar 20, 2017

Study Type

Interventional

Conditions

Insomnia Disorder

Summary

The aim of this study is to use a morning dose of armodafinil (50mg) as a short-term aid (4-weeks) to protect against daytime impairments in those with Insomnia Disorder who are undergoing effective sleep restriction therapy. We hypothesise that overall insomnia severity measured through self-report of the Insomnia Severity Index (Primary Outcome) at 12 weeks (14 weeks into study protocol) from the start of treatment will reduce significantly more in patients receiving adjunctive armodafinil and sleep restriction therapy compared to those receiving sleep restriction therapy only (non-drug historical controls). This may then increase adherence by augmenting wakefulness and in turn promote sleep in those with Insomnia Disorder. This is in line with a previous finding involving modafinli and overall CBT-I for insomnia (Perlis et al., 2004, SLEEP, Vol 27). This will be the first study to fully profile the acute effects of sleep restriction therapy + armodafinil for the treatment of insomnia. This study is a pilot study to determine acceptability, safety, efficacy and tolerability of armodafinil specifically in the context of sleep restriction therapy alone for Insomnia Disorder.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria7

Males & Females aged 18-70 years.
Able to give informed written consent.
Literacy in English.
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.
Insomnia Severity Index scale scores of 15 or more.
Never previously treated with CBT-I or armodafinil.
At least one month hypnotic free and willing to not take hypnotics for the duration of the trial.

Exclusion Criteria10

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

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Interventions

30 patients with insomnia will be asked to undergo sleep restriction therapy with armodafinil. This is an open label pilot study to determine if armodafinil is acceptable, tolerated, and ameliorates the side effects of sleep restriction therapy. As part of sleep restriction therapy, participants will be asked to ‘restrict’ their sleep-wake schedules (the minimum time in bed for all participants will be at least five hours). This causes excessive sleepiness, fatigue, & irritability during the initial stages. It is hypothesised that the use of armodafinil will prevent these transient effects of sleep loss. As part of one hour long intervention, participants are instructed to keep a stable bedtime and wake-up time for the length of the treatment (4 weeks). The therapist will devise a "sleep window" that is approved by the participant. The sleep window will be evaluated every week for four weeks via telephone (10 minutes). Time in bed may be modified at weekly intervals by the achievement of 90% sleep efficiency (SE) = Total sleep time / Time in bed * 100) from a one week sleep diary (10 minute session per week via telephone). If 90% SE is achieved on average for any week of the therapy then time in bed is expanded by 15 minutes (either at bedtime or in the morning, depending on the participant). If <85% SE is achieved time in bed is reduced by 15 minutes (but not if it is at the minimum of five hours). If SE = 85-90% Time in bed is held constant. For patients who deem the sleep window too difficult, restrictive, or impossible compromise will be established between the therapist and the patient. Armodafinil (initially 50mg, rising in 50mg amounts to a maximum of 150mg oral dose) once daily (to be taken before 09:00 am) for four weeks during SRT for Insomnia Disorder only. Up titration of armodafinil will take place based on the discretion of the assigned medical practitioner in consultation with the patient. Participants will be prescribed armodafinil by their assigned medical practitioner as part of the first visit to receive sleep restriction therapy. The weekly telephone calls to monitor the effects of sleep restriction therapy will also be used as a method to raise any concerns regarding the use and dose of armodafinil. The assigned medical practitioner will be informed of this and will decide if any action is required. The intervention will end after four weeks of treatment. Adherence to armodafinil will be established with drug tablet return. Adherence to sleep restriction therapy will be evaluated by sleep-wake dairies, actigraphy and a specific weekly sleep restriction therapy adherence scale.