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NOT YET RECRUITING
NCT07323121
NA

40 Hz Flickering for Insomnia in Parkinson's Disease

Sponsor: Jiangsu Province Nanjing Brain Hospital

View on ClinicalTrials.gov

Summary

This randomized, single-blind, controlled clinical trial aims to evaluate the efficacy and safety of 40 Hz flicker light stimulation for insomnia in patients with Parkinson's disease (PD). Patients with PD and clinically significant insomnia will be randomly assigned in a 1:1 ratio to receive either 40 Hz flicker light or control light for 30 minutes every night at bedtime for 7 consecutive days, in addition to standard antiparkinsonian treatment. The primary objective is to determine whether 40 Hz flicker light stimulation improves PD-related insomnia as measured by Parkinson's Disease Sleep Scale-2 (PDSS-2). Secondary objectives include evaluating changes in polysomnography-derived sleep parameters, subjective sleep quality, and other non-motor symptoms, as well as assessing the safety and tolerability of the intervention. This registration specifically covers the Parkinson's disease insomnia cohort of a larger, previously approved multi-cohort protocol that also includes healthy volunteers and primary insomnia patients.

Official title: Randomized, Single-blind, Controlled Study of 40 Hz Flickering Stimulation for Insomnia and Other Non-motor Symptoms in Patients With Parkinson's Disease

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-01-01

Completion Date

2026-12-31

Last Updated

2026-01-07

Healthy Volunteers

No

Interventions

DEVICE

40 Hz flicker light device

A visual stimulation device delivering flicker light at 40 Hz. Participants assigned to this intervention receive 30 minutes of 40 Hz flicker light stimulation every night at bedtime for 7 consecutive days, in addition to their stable antiparkinsonian medication. Device parameters, including light intensity and distance, are adjusted according to the protocol to ensure safety and comfort.

DEVICE

100 Hz flicker light device

A visual stimulation device delivering 100 Hz light (e.g., steady or low-frequency light) with similar appearance and intensity as the 40 Hz device. Participants assigned to this intervention receive 30 minutes of control light exposure every night at bedtime for 7 consecutive days, in addition to their stable antiparkinsonian medication.