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NCT01338649 · ClinicalTrials.gov registry record · NA
Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence
A NA study, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 27
- Enrollment target
NCT01338649 is a NA study that has completed, run by Northwestern University. The registered enrollment target is 27 participants.
The verdict
NCT01338649, a NA study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 27 participants
- Enrollment target
Study Summary
Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective (sleep logs/scales) sleep measures will be collected through the baseline and intervention phases of the study. The primary outcome measure will be the change in the Epworth Sleepiness Scale (ESS) comparing the bright light treatment with dim-red light treatment. Secondary outcome measures will include the Multiple Sleep Latency Test (MSLT), global Pittsburgh Sleep Quality Index (PSQI) score, Parkinson's Disease Sleep Scale (PDSS) score, and actigraphy measures. A variety of exploratory analyses will examine the effects of bright light treatment on fatigue, depression, quality of life, cognition, and motor disability. Hypothesis: Bright light exposure will diminish daytime sleepiness and improve night-time sleep in PD patients with daytime sleepiness.
Interventions
- DEVICE Bright Light Treatment (Sun Ray Sunbox SB-558)
- DEVICE Dim red light (Sun Ray Sunbox SB-558)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2007-11 |
| Est. Completion | 2012-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01338649
The ClinicalTrials.gov registry entry for NCT01338649 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Bright Light Treatment (Sun Ray Sunbox SB-558) is the first listed.
NCT01338649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01338649 about?
NCT01338649 is a clinical study titled "Light Therapy Treatment in Parkinson's Disease Patients With Daytime Somnolence". Study objectives are to determine the efficacy, safety and tolerability of bright light treatment in Parkinson's Disease (PD) patients with daytime sleepiness. Thirty PD patients will be enrolled and equally randomized to bright light or dim-red light treatment. Objective (actigraphy) and subjective...
What is the current status of trial NCT01338649?
This trial is currently completed. It is a NA study. The enrollment target is 27 participants. The study started on 2007-11. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01338649?
The interventions under investigation include: Bright Light Treatment (Sun Ray Sunbox SB-558) (DEVICE), Dim red light (Sun Ray Sunbox SB-558) (DEVICE).
Who is sponsoring clinical trial NCT01338649?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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