Clinical trial NCT01489982: Treatments for Insomnia in Patients With Parkinson's Disease
Official title: Treatments for Insomnia in Patients With Parkinson's Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Parkinson's Disease
Insomnia
Keywords: Parkinson's disease
insomnia
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2011-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 the general population very few studies have been conducted with Parkinson's Disease (PD) patients. Insomnia in PD has unique characteristics and pathophysiology; therefore, measures to treat insomnia in the general population may be ineffective in PD.

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.

Participants will come for four visits: for screening, then in 1 week, 3 weeks and 7 weeks. Study visits should take approximately 1.5 to 2 hours. During the entire period of the study, the participant will be wearing a wrist actigraph - this is a motion sensing device the size of a wristwatch. Specific instructions how to use this device and how to use the sleep diary will explained at the first visit. Participant will also be filling out sleep diaries every day, to keep track of how many hours you sleep, etc. During each of the study visits there will be an in-depth interview, and researcher will review with the participants their sleep diaries and troubleshoot any problems.

In this trial the investigators will be testing three main treatment strategies. The treatment that the patient will receive first will be chosen randomly - this is essential to properly test our strategies. Participant will know which group he/she has been assigned to. If the first therapy has not been effective for the patient, he/she may choose to re-enroll in the trial, in which case participant will receive one of the remaining two therapies. The therapies are:

1. Light therapy, which patient will use for 30 minutes, starting at two hours (+/- 1 hour) before your usual bedtime. Light boxes will be provided by our team. Patient will be instructed how to use this light.
2. Cognitive behavioural therapy and sleep hygiene training - This 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 totaling 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.
3. Insomnia medications - In this portion patient will receive medications to help them sleep. Depending on the type of patient's sleep problem, this will either be a medication called desipramine (also called Doxepin), or zopiclone (also called Imovane). Both of these medications are currently used for insomnia in people without Parkinson's. These medications will be prescribed exactly as any other medical prescription, and participant will take them as any other medical prescription.

Eligibility 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).

Primary outcomes:
measure: SCOPA sleep scale
timeFrame: 6 weeks
measure: Actigraphy
timeFrame: 6 weeks
Secondary outcomes:
measure: Daily sleep dairy
timeFrame: 6 weeks
measure: Insomnia severity Index (ISI)
timeFrame: 6 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 weeks
measure: Parkinson's Disease Sleep Scale (PDSS)
timeFrame: 6 weeks
measure: Clinical global impression of change
timeFrame: 6 weeks
measure: The Krupp Fatigue Severity Scale
timeFrame: 6 weeks
measure: Beck depression index
timeFrame: 6 weeks
measure: Adherence to treatment
timeFrame: 6 weeks
measure: Severity of motor manifestations (UPDRS)
timeFrame: 6 weeks
measure: Quality of life (PDQ-39)
timeFrame: 6 weeks
measure: Adverse events
timeFrame: 6 weeks
measure: Sleep Hygiene Index
timeFrame: 6 weeks
measure: Dysfunctional Beliefs and Attitudes about Sleep, a brief version ( DBAS 16)
timeFrame: 6 weeks
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal General Hospital
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Ronald Postuma, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: