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Light Therapy for PD - Dose Selection

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ClinicalTrials.gov Identifier: NCT04291014
Recruitment Status : Active, not recruiting
First Posted : March 2, 2020
Last Update Posted : December 14, 2022
Sponsor:
Information provided by (Responsible Party):
Aleksandar Videnovic, MD, Massachusetts General Hospital

Study Description
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Brief Summary:
This study aims to determine the most effective dose of light therapy to improve sleep in people with Parkinson's Disease. Four groups of participants will receive bright-white or dim-red light therapy at different times throughout the day.

Condition or disease Intervention/treatment Phase
Parkinson Disease Sleep Disorder Fatigue Device: SunRay Light Boxes Not Applicable

Detailed Description:
This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a 16-week, randomized, phase II, parallel-group, dose-selection clinical trial of LT in participants with PD and co-existing sleep disruption using a comparative selection trial design.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose Selection Trial of Light Therapy for Impaired Sleep in Parkinson's Disease
Actual Study Start Date : September 11, 2020
Actual Primary Completion Date : November 12, 2022
Estimated Study Completion Date : April 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BWLT once daily
Participants in this arm will receive bright white light therapy daily once a day (in the evening)
 Device: SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
Experimental: BWLT twice daily
Participants in this arm will receive bright white light therapy daily twice a day (morning and evening).
 Device: SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
Experimental: BWLT weekly
Participants in this arm will receive bright white light therapy once weekly (in the evening).
 Device: SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.
Experimental: DRLT twice daily
Participants in this arm will receive dim red light twice daily (morning and evening).
 Device: SunRay Light Boxes
SunRay light boxes will be used to administer the light therapy.


Outcome Measures
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Primary Outcome Measures :
  1. PDSS-2 [ Time Frame: 8 weeks ]
    The PDSS-2 is a 15-question instrument designed to simultaneously capture the multidimensional aspects of sleep-related problems and changes in sleep quality.


Secondary Outcome Measures :
  1. PFS-16 [ Time Frame: 8 weeks ]
    The PFS-16 is a patient-rated scale that measures fatigue. The scale allows the measurements of the presence of fatigue (seven items) and its impact on daily function (nine items).


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of idiopathic PD as defined by the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease;
  2. PD Hoehn and Yahr stage 2-4;
  3. A score of 2 (mild) or above on the Sleep Problems question of the MDS-UPDRS Part 1;
  4. Stable dose of all PD medications for at least 30 days prior to randomization;
  5. Willingness to wear an Actiwatch and complete daily sleep logs;
  6. Age 45 or above

Exclusion Criteria:

  1. Atypical or secondary forms of parkinsonism;
  2. Co-existent significant sleep apnea at screening, as determined by the PI's clinical assessment; adequately treated sleep apnea, as assessed by sleep apnea machine download (CPAP download) will be permitted;
  3. Co-existent symptomatic restless legs syndrome (RLS) (as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS) at screening;
  4. Cognitive impairment as determined by a Mini Mental State Examination score <25 at screening;
  5. Presence of moderate depression defined as a Beck Depression Inventory II (BDI-II) score ≥20 at screening;
  6. Current untreated hallucinations or psychosis (drug-induced or spontaneous) with a score of 2 or above on the Hallucinations and Psychosis question of the MDS-UPDRS Part 2;
  7. Use of hypno-sedative drugs for sleep or stimulants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
  8. Ongoing or recent (within 30 days prior to screening) Cognitive Behavioral Therapy for Insomnia;
  9. Use of antidepressants, unless the participant has been on a stable dose for at least 60 days prior to the screening;
  10. Work hours between 10 PM and 6 AM, within 60 days prior to randomization or anticipated during the 16 weeks after screening;
  11. Travel between 3 or more time zones within 45 days prior to study screening or anticipated such travel during the 16 weeks after screening;
  12. Unstable or serious medical illness;
  13. History of significant eye trauma or disease, retinopathy, or cataract Grade 4 that would significantly affect transmission or processing of light through either eye;
  14. Current use, use at any time during study participation, or use within the 30 days prior to screening of photosensitizing or other medications that in the opinion of the investigator would interfere with the safety of the participant during the trial, including: amiodarone, porfimer, psoralens, chlorpromazine, quinidine, demeclocycline, temoporfin, tetracycline, fleroxacin, oral isoretinoin, voriconazole, nalidixic acid, thioridazine, St. John's wort, ofloxacin, and piroxicam;
  15. Pregnant women will be excluded from participation; if a participant is pre-menopausal, a urine pregnancy test will be conducted at randomization to determine eligibility.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04291014


Locations
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Sponsors and Collaborators
Massachusetts General Hospital
More Information
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Publications:

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Responsible Party: Aleksandar Videnovic, MD, Associate Professor of Neurology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04291014    
Other Study ID Numbers: NN110 1U01NS114001
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: December 14, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: This trial will follow the NINDS policy for data sharing.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aleksandar Videnovic, MD, Massachusetts General Hospital:
Parkinson Disease
Light therapy
Additional relevant MeSH terms:
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Parkinson Disease
Sleep Wake Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Neurologic Manifestations
Mental Disorders