Treatments for Insomnia in Patients With Parkinson's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 28 April 2015
• Main ID: NCT01489982
• Date of registration: 19/07/2011
• Prospective Registration: No
• Primary sponsor: McGill University Health Center
• Public title: Treatments for Insomnia in Patients With Parkinson's Disease
• Scientific title: Treatments for Insomnia in Patients With Parkinson's Disease: A Pilot Study
• Date of first enrolment: January 2011
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01489982
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
• Phase: Phase 0

Countries of recruitment

Canada

Contacts

• Name: Ronald Postuma, MD, MSc
• Affiliation: McGill University Health Center

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Insomnia

Parkinson's Disease

Intervention(s)

Drug: Doxepin and Zopiclone

Device: Light box ( Litebook company)

Device: Light box (Litebook company)

Behavioral: CBT and sleep hygiene

Primary Outcome(s)

SCOPA sleep scale [Time Frame: 6 weeks]

Actigraphy [Time Frame: 6 weeks]

Secondary Outcome(s)

Adverse events [Time Frame: 6 weeks]

Dysfunctional Beliefs and Attitudes about Sleep, a brief version ( DBAS 16) [Time Frame: 6 weeks]

Adherence to treatment [Time Frame: 6 weeks]

Beck depression index [Time Frame: 6 weeks]

Parkinson's Disease Sleep Scale (PDSS) [Time Frame: 6 weeks]

Severity of motor manifestations (UPDRS) [Time Frame: 6 weeks]

Daily sleep dairy [Time Frame: 6 weeks]

Pittsburgh Sleep Quality Index (PSQI) [Time Frame: 6 weeks]

Clinical global impression of change [Time Frame: 6 weeks]

Sleep Hygiene Index [Time Frame: 6 weeks]

Insomnia severity Index (ISI) [Time Frame: 6 weeks]

Epworth Sleepiness Scale (ESS) [Time Frame: 6 weeks]

Quality of life (PDQ-39) [Time Frame: 6 weeks]

The Krupp Fatigue Severity Scale [Time Frame: 6 weeks]

Secondary ID(s)

INS-09-10

Source(s) of Monetary Support

Please refer to primary and secondary sponsors