Treatments for Insomnia in Patients With Parkinson's Disease

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University Health Center; McGill University Health Centre/Research Institute of the McGill University Health Centre
• Treatments: Doxepin; Zopiclone

Criteria

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).