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Treatments for Insomnia in Patients With Parkinson's Disease

NCT01489982 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-04-16

No results posted yet for this study

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

Interventions

DEVICE

Light box (Litebook company)

Light therapy will be administered daily for a duration of 30 minutes, starting two hours (+/- 1 hour) prior to usual bedtime

BEHAVIORAL

CBT and sleep hygiene

6 weekly sessions totalling 90 minutes

DRUG

Doxepin and Zopiclone

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)

DEVICE

Light box ( Litebook company)

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

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Ronald Postuma, MD, MSc · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01489982 on ClinicalTrials.gov