Light Therapy in Parkinson's Disease

Soochow University

Status: Enrolling

Conditions: Sleep Disorder; Parkinson Disease; Circadian Rhythm Disorders

Treatments: Device: Bright light box; Device: Dim Light box

Study type: Interventional

Funder types: Other

Identifiers

NCT06129942

JD-LK2020062-R02

Details and patient eligibility

About

The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.

Full description

As the most important biologic rhythm timer, exogenous light supplement has certain benefits for the improvement of sleep quality and dementia. At present, it is gradually used in sleep and neuropsychiatric diseases. In an open study, 120 patients with PD received 4000 to 6000 lux of light, for 60 minutes before habitual bedtime. The patients were followed up for several months to 8 years, and it found the patients who persisted in the treatment improved their mood, anxiety and motor function. Clinical studies have confirmed the safety and effectiveness of light in improving insomnia and daytime sleepiness of PD patients. It was found that strong light can significantly improve the patients' motor and non-motor symptoms. However, these findings have not been reported in Chinese PD patients. The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease and explore the possible mechanism.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• According to the criteria of PD diagnosis of the MDS, PD patients were selected as the research object. The clinical symptoms of PD patients were consistent with Hoehn and Yahr stages 2-3.
• All PD patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period.

Exclusion criteria

• Using hypnotic or stimulating drugs.
• Using antidepressants, except stable drugs maintained for more than three months;
• Visual impairment, such as cataract, glaucoma, blindness, etc;
• Cognitive impairment (MMSE < 24);
• There are uncontrollable hallucinations and mental diseases;
• There are sleep phase delay / advance syndrome, shift work, jet lag, etc

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Dim light group

Placebo Comparator group

Description:

treated with the placebo device which operates with one intensity of 300 lux \* 1 month

Treatment:

Device: Dim Light box

Bright light group

Experimental group

Description:

treated with the experimental device which operates with one intensity of 10,000 lux \* 1 month

Treatment:

Device: Bright light box