Parkinson's Disease | Treatments for Insomnia in Patients With Parkinson's Disease
Parkinson's Disease research study
What is the primary objective of this study?
More than half of patients with Parkinson's have troubles with insomnia. There are several treatment options for insomnia that have been studied in the general population - however, the investigators don't know if these treatments work for patients with Parkinson's. It is possible that people with Parkinson's may have different treatment responses. The goal of this project is to test in a pilot study the tolerability and effectiveness of pharmacologic and non-pharmacologic treatments to improve insomnia in patients with Parkinson's disease. Each participant in this study will be wearing a wrist actigrapch and fill out the sleep diary. Three main treatment strategies will be tested: Placebo Light therapy, Cognitive behavioural therapy and active light therapy, and insomnia medications. The treatment that each person will receive first will be chosen randomly. If the first therapy has not been effective, participant may choose to re-enrol in the trial with one of the remaining two therapies.
Who is eligible to participate?
Inclusion Criteria: - All patients will be recruited from the Movement Disorder Clinics at the McGill University Health Center. - Patients will be eligible for inclusion if they have a diagnosis of idiopathic PD and suffer from insomnia, defined as an SCOPA-sleep nocturnal subscore of >7. - The insomnia must have been persistent for at least 6 months (by patient self-report). - The subjects must speak either English or French sufficiently to fill out questionnaires. Exclusion Criteria: 1. Use of sedative medications at night (including sedating antidepressants). Patients may be taking non-sedating antidepressants if dose is stable for 1 month. 2. Untreated restless legs syndrome, night shift work, occupational causes of abnormal sleep pattern, or other reversible causes of insomnia detected upon baseline clinical interview. If treatment of a potentially-reversible cause is unsuccessful and insomnia is persistent >3 months following treatment initiation, patients can be enrolled. 3. Insomnia is not secondary to suboptimal dopaminergic therapy. If changes to dopaminergic therapy are required after clinical interview, patients can still be eligible for inclusion if insomnia is persistent >3 months. 4. Pre-menopausal women who are not using effective methods of birth control (note that only a small minority of women with PD are pre-menopausal, so the effects of this exclusion criterion in creating gender imbalance should be minimal). 5. Dementia, defined according to PD dementia criteria as MMSE <26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process. 6. Change to dopaminergic therapy over the preceding three months. 7. Patients with very severe PD, defined as Hoehn and Yahr of 5 (i.e. nonambulatory). Provision of sleep hygiene measures, etiology of insomnia, and potential confounds in interpretation of actigraphy in immobile patients is problematic in very advanced stages of PD. 8. Insomnia is related to untreated moderate-severe depression or anxiety. Beck depression score > 20i.e, moderate depression).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Light box (Litebook company)Light therapy will be administered daily for a duration of 30 minutes, starting two hours (+/- 1 hour) prior to usual bedtime
Behavioral:CBT and sleep hygiene6 weekly sessions totalling 90 minutes
Drug:Doxepin and ZopicloneZopiclone 3.75 mg at h.s., increasing to 7.5 mg after one week if insufficient clinical effects ( and no troublesome side effects) or Doxepin 5 mg at h.s. followed by increase up to 10 mg after the first week if insufficient clinical effect (and no troublesome side effects)
Device:Light box ( Litebook company)The intervention will be 30 minutes of light therapy, using red light below the threshold required to entrain light cycles
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Light therapyFor patients who have sleep maintenance insomnia light therapy will be administered daily. If patients suffer only from sleep onset insomnia, this light therapy will be given upon awakening in the morning. Light boxes will be provided by Litebook company. In the active therapy group, the intensity of the light will be set at 10,000 lux with a head-to-light distance of 20cm. Patients will be instructed to let the light shine indirectly on their eyes (i.e. they do not look directly at the light). Patients can be reading, eating, watching TV, etc., during the time of light therapy.
CBT and sleep hygiene trainingThis will involve education about sleep in general, giving techniques related to sleep and relaxation, tips on stress management, etc.. This will take place at the Lady Davis Institute of the Jewish General Hospital. There will be 6 weekly sessions totalling 90 minutes - most of the time this will be in a group setting, with a maximum of 6 patients per group. Light therapy will also be part of this treatment strategy. There will be separate gropus for English and French-speaking patients
Insomnia medicationsPharmacologic treatment will be individualized depending on patient characteristics and initial response. It will consist of two potential treatments - Doxepin or Zopiclone. Both of these agents are currently used commonly in the general population and also in PD patients. The agents will be prescribed exactly as any other medical prescription (i.e. patients will fill their own prescriptions at their own pharmacy).The decision for which agent to use will be as follows: a)If patients suffer from sleep onset insomnia (with or without sleep maintenance insomnia), or if doxepin is contraindicated, Zopiclone will be prescribedb) or b)If patients suffer from sleep maintenance insomnia only (or if Zopiclone is contraindicated), Doxepin will be the first choice agent.
Placebo intervention of light therapyThe inactive/placebo intervention will be 30 minutes of light therapy, using red light below the threshold required to entrain light cycles. This therefore functions as a placebo condition for the active light therapy protocol. Patients be informed that some forms of light therapy will be expected to be less active, but we will not disclose what type of condition is inactive.
Start Date: January 2011
Completed Date: December 2012
Phase: Early Phase 1
Primary Outcome: SCOPA sleep scale
Secondary Outcome: Daily sleep dairy
Study sponsors, principal investigator, and references
Principal Investigator: Ronald Postuma, MD, MSc
Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre