Status:
COMPLETED
Treatments for Insomnia in Patients With Parkinson's Disease
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Parkinson's Disease
Insomnia
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 ...
Detailed Description
There are now a variety of treatments that can help to manage insomnia, including non-pharmacological and pharmacologic measures. Although many of these strategies have been proven to be effective in ...
Eligibility Criteria
Inclusion
- 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
- Use of sedative medications at night (including sedating antidepressants). Patients may be taking non-sedating antidepressants if dose is stable for 1 month.
- 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.
- 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.
- 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).
- Dementia, defined according to PD dementia criteria as MMSE \<26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process.
- Change to dopaminergic therapy over the preceding three months.
- 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.
- Insomnia is related to untreated moderate-severe depression or anxiety. Beck depression score \> 20i.e, moderate depression).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01489982
Start Date
January 1 2011
End Date
December 1 2012
Last Update
April 16 2015
Active Locations (1)
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1
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4