Bright Light Therapy for Non-motor Symptoms in Parkinson's Disease

NCT ID: NCT02909192

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2026-11-30

Brief Summary

Disruption of sleep and alertness is one of the most disabling non-motor symptoms of Parkinson's disease (PD). Mechanisms leading to impaired sleep and alertness in PD are not well understood, and treatment options remain limited. The proposed research will examine markers of the circadian system, sleepiness and sleep quality in PD patients. Further, the project will examine effects of bright light exposure on circadin function, sleep and alertness in PD.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bright light therapy

Participants will be treated twice daily with bright light therapy.

Group Type: ACTIVE_COMPARATOR

Light Therapy Device

Intervention Type: DEVICE

Dim-Red light therapy

Participants will be treated twice daily with dim-red light therapy.

Group Type: ACTIVE_COMPARATOR

Light Therapy Device

Intervention Type: DEVICE

Interventions

Light Therapy Device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of idiopathic PD as defined by the United Kingdom PD Society Brain Bank Criteria

2. PD Hoehn and Yahr stage 2-4

3. Pittsburgh Sleep Quality Index (PSQI) score ≥ 5

4. Treatment with levodopa and/or dopamine agonist; adjunctive PD medications will be allowed

5. Stable dose of PD medications for at least 4 weeks prior to the study screening.

Exclusion Criteria

1. Atypical or secondary forms of parkinsonism

2. Co-existent significant sleep apnea (as assessed by polysomnography- derived apnea/hypopnea index ≥15 events/hr of sleep)

3. Co-existent restless legs syndrome (RLS), as assessed by the International Classification of Sleep Disorders (ICDS) diagnostic criteria for RLS

4. Cognitive impairment as determined by the Mini-Mental State Examination (MMSE) score of ≤ 26

5. Presence of depression defined as the Beck Depression Inventory (BDI) score >14

6. Untreated hallucinations or psychosis (drug-induced or spontaneous)

7. Use of hypno-sedative drugs for sleep or stimulants; participants will be allowed to taper these drugs and will become eligible 4 weeks after the taper is completed

8. Use of Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) antidepressants, unless the participant has been on a stable dose for at least 3 months prior to the screening

9. Use of medications known to affect melatonin secretion, such as lithium, alpha- and beta-adrenergic antagonists

10. Shift work, currently or within the prior 3 months

11. Travel through ≥ 2 time zones within 60 days prior to study screening

12. Hematocrit <32 mm3

13. Pre-existing glaucoma/retinal disease contraindicated for light therapy (LT)

14. Dense cataracts

15. Use of medications known to photosensitize retinal tissue (phenothiazines, chloroquine, amiodarone, St. John's Wort)

16. Unstable/serious medical illness.

17. Pregnancy

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aleksandar Videnovic, MD

Assistant Neurologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleksandar Videnovic, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2016P001775

Identifier Type: -

Identifier Source: org_study_id