Treatments for Insomnia in Patients With Parkinson's Disease

NCT01489982 | Completed Early Phase 1

• 1 other identifier: INS-09-10
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease; Insomnia

Keywords

Parkinson's disease; insomnia

Outcome Measures

Primary Outcomes (2)

• SCOPA sleep scale

  The SCOPA sleep scale is a disease-specific measure that has been designed to assess sleep in PD. It is divided into two sections which address occurrence of nighttime sleep problems and daytime sleepiness in PD over the past month. It has been recommended as a scale of choice for evaluation of insomnia by the Movement Disorders Task Force for Sleep assessment in PD. A nocturnal subscale score of \>7 was proposed as a cutoff to define poor sleep, based upon the global sleep assessment, a cutoff confirmed in a subsequent study.

  6 weeks

• Actigraphy

  Actigraphs are motion sensing devices the size of a wristwatch, which are constantly worn by the patient. Absence of physical activity for a prolonged interval is interpreted as onset of sleep The actigraph used will be the ActiWatch Spectrum (Philips Respironics). The primary outcomes of interest with actigraphy will be total sleep time, sleep efficiency, wake after sleep onset, sleep fragmentation, and duration and number of naps (sleep onset latency will also be assessed, but will be supplemented mainly with diary, since onset latency is not reliably assessed with actigraphy).

  6 weeks

Secondary Outcomes (14)

• Daily sleep dairy

  6 weeks

• Insomnia severity Index (ISI)

  6 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  6 weeks

• Parkinson's Disease Sleep Scale (PDSS)

  6 weeks

• Clinical global impression of change

  6 weeks

Study Arms (4)

Light therapy

EXPERIMENTAL

For 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.

Device: Light box (Litebook company)

CBT and sleep hygiene training

EXPERIMENTAL

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 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

Behavioral: CBT and sleep hygiene

Insomnia medications

EXPERIMENTAL

Pharmacologic 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.

Drug: Doxepin and Zopiclone

Placebo intervention of light therapy

PLACEBO COMPARATOR

The 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.

Device: Light box ( Litebook company)

Interventions

Light box ( Litebook company) DEVICE

The intervention will be 30 minutes of light therapy, using red light below the threshold required to entrain light cycles

Placebo intervention of light therapy

CBT and sleep hygiene BEHAVIORAL

6 weekly sessions totalling 90 minutes

CBT and sleep hygiene training

Doxepin and Zopiclone DRUG

Zopiclone 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)

Insomnia medications

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients will be recruited from the Movement Disorder Clinics at the McGill University Health Center.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders

Interventions

Doxepin; zopiclone

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Oxepins; Ethers, Cyclic; Ethers; Organic Chemicals; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ronald Postuma, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: December 12, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 16, 2015

Record last verified: 2015-04

Locations

CA (1)