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light-therapy-pd-nct06129942
Light Therapy in Parkinson's Disease
Overview
Light Therapy in Parkinson's Disease
Overview
This clinical trial investigates the effects of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease. The study is conducted at the Second Affiliated Hospital of Soochow University in Suzhou, China.
Bright light therapy is a non-invasive intervention that uses controlled exposure to bright artificial light to help regulate circadian rhythms. In Parkinson's disease, circadian rhythm disturbances are common and contribute to sleep disorders, mood disturbances, and potentially motor symptom fluctuations.
Trial Details
| Parameter | Value |
|-----------|-------|
| NCT Number | NCT06129942 |
| Title | Light Therapy in Parkinson's Disease |
| Status | Recruiting |
| Phase | Not Applicable |
| Sponsor | Second Affiliated Hospital of Soochow University |
| Principal Investigator | Chun-Feng Liu, PhD |
| Enrollment | 50 participants (estimated) |
| Start Date | September 1, 2021 |
| Primary Completion | May 16, 2026 (estimated) |
| Location | Suzhou, Jiangsu, China |
Study Design
| Design Element | Details |
|----------------|---------|
| Type | Interventional |
| Allocation | Randomized |
| Intervention Model | Crossover |
| Primary Purpose | Treatment |
| Masking | Double-blind (Participant, Investigator) |
Intervention Arms
Bright Light Group (Experimental)
Patients receive bright light therapy using a light box operating at 10,000 lux intensity:
- Duration: 1 hour daily
- Timing: 08:00-11:00 in the morning and 17:00-19:00 in the afternoon
- Treatment Period: 1 month
- Distance: Within 65cm from the light box
- Instructions: Patients should move under the light source but should not fall asleep
The light box uses a spectrally transparent prism diffuser that blocks ultraviolet rays while preserving light quality.
Dim Light Group (Control/Placebo)
Patients receive placebo treatment using a device operating at 300 lux intensity:
- Duration: 1 hour daily
- Timing: 08:00-11:00 in the morning and 17:00-19:00 in the afternoon
- Treatment Period: 1 month
- Distance: Within 65cm from the light box
Mechanism of Action
Circadian Rhythm Dysfunction in PD
Parkinson's disease is associated with significant circadian rhythm disturbances:
Light Therapy Mechanism
Bright light therapy exerts its effects through:
Rationale for Light Therapy in PD
Clinical evidence suggests bright light therapy may benefit PD patients through:
- Sleep improvement: Enhanced sleep quality and efficiency
- Mood enhancement: Reduction in depressive symptoms
- Motor symptom modulation: Potential improvement in motor function
- Non-motor symptom relief: Addressing circadian-related non-motor symptoms
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
- Using hypnotic or stimulating drugs
- Sleep phase delay/advance syndrome
- Shift work or jet lag
- Visual impairment (cataract, glaucoma, blindness)
- Cognitive impairment (MMSE < 24)
- Uncontrollable hallucinations
- Mental diseases
- Antidepressants (except if stable for >3 months)
Outcomes
Primary Outcomes
| Outcome | Assessment Timing |
|---------|-------------------|
| Total Sleep Time (TST) by polysomnography | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Sleep Efficiency by polysomnography | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| REM Sleep Without Atonia (RWA) by PSG | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Sleep Onset Latency by PSG | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Periodic Limb Movement during Sleep (PLMS) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Sleep Stage Duration and Percentage | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Slow Wave Activity (SWA) and Slow Wave Energy (SWE) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
Secondary Outcomes
| Outcome | Assessment Timing |
|---------|-------------------|
| MDS-UPDRS Score | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Hoehn-Yahr Scale | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| PDSS-2 (Parkinson's Disease Sleep Scale-2) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| PSQI (Pittsburgh Sleep Quality Index) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| RBDQ-HK (REM Sleep Behavior Disorder Questionnaire-Hong Kong) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| ESS (Epworth Sleepiness Scale) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| MEQ (Morningness-Eveningness Questionnaire) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| HAMA (Hamilton Anxiety Scale) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| HAMD-24 (Hamilton Depression Scale-24) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| MoCA (Montreal Cognitive Assessment) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| NMSQ (Non-Motor Symptoms Questionnaire) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| PDQ-39 (Parkinson's Disease Questionnaire-39) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| FSS (Fatigue Severity Scale) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| EEG (Electroencephalogram) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Melatonin rhythmic level (serum and saliva) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| Cortisol rhythmic level (serum and saliva) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
| fMRI (functional Magnetic Resonance Imaging) | Visit 1 (baseline), Visit 2 (Week 4), Visit 3 (Week 8), Visit 4 (Week 12) |
Significance for Parkinson's Disease
Sleep Disorders in PD
Sleep disturbances are among the most common non-motor symptoms in Parkinson's disease:
- REM Sleep Behavior Disorder (RBD): Present in up to 50% of PD patients
- Insomnia: Difficulty initiating or maintaining sleep
- Excessive daytime sleepiness: Present in up to 40% of patients
- Periodic limb movement disorder: Affects sleep quality
Current Treatment Limitations
Current PD therapies primarily target:
- Dopamine replacement (levodopa, agonists)
- Deep brain stimulation
- Physical therapy
However, these do not adequately address circadian rhythm disturbances.
Potential Benefits of Light Therapy
Light therapy offers several advantages:
Comparison with Other Light Therapy Studies for PD
| Study | Intensity | Duration | Key Findings |
|-------|-----------|----------|--------------|
| This trial (NCT06129942) | 10,000 lux | 1 month | PSG sleep metrics, MDS-UPDRS |
| Videnovic et al. 2017 | 10,000 lux | 2 weeks | Improved sleep quality, daytime sleepiness |
| Rutten et al. 2019 | 10,000 lux | 6 weeks | Improved depression scores |
| Paus et al. 2007 | 5,000 lux | 4 weeks | Improved motor scores |
Cross-Links
- [Parkinson's Disease](/diseases/parkinsons-disease)
- [Sleep Disorders in Parkinson's Disease](/diseases/parkinsons-disease)
- [Circadian Rhythm](/diseases/circadian-rhythm-disorders)
- [Melatonin](/proteins/melatonin)
- [Suprachiasmatic Nucleus](/brain-regions/suprachiasmatic-nucleus)
- [Non-Motor Symptoms of PD](/diseases/parkinsons-disease)
Contact Information
- Principal Investigator: Chun-Feng Liu, PhD
- Institution: Second Affiliated Hospital of Soochow University
- Department: Department of Neurology
- City: Suzhou, Jiangsu, China
- Phone: +86 512 67783307
- Email: liuchunfeng@suda.edu.cn
References
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