40 Hz Flickering for Insomnia in Parkinson's Disease

NCT07323121 | Not Yet Recruiting DMC

• 2 other identifiers: 2022-130-K-99-0182430045
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Parkinson Disease; Insomnia

Keywords

Parkinson's disease; insomnia; sleep disorders; 40 Hz flickering; gamma oscillation

Outcome Measures

Primary Outcomes (1)

• Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score (0-60 points; higher scores indicate worse sleep disturbance).

  The Parkinson's Disease Sleep Scale-2 (PDSS-2) is a 15-item questionnaire assessing nocturnal symptoms in Parkinson's disease. Each item is scored from 0 to 4, yielding a total score from 0 to 60 points. Higher scores indicate more severe sleep disturbance. The outcome measure is the change in PDSS-2 total score from baseline to Day 7 after the intervention, and the between-group difference (40 Hz vs control) in mean change will be compared.

  Baseline and Day 7

Secondary Outcomes (2)

• Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score at follow-up (0-60 points; higher scores indicate worse sleep disturbance).

  Baseline, Day 7, and Day 28

• Change in Non-Motor Symptoms Scale (NMSS) total score (0-360 points; higher scores indicate more severe non-motor symptoms).

  Baseline and Day 7

Study Arms (2)

40 Hz flicker light stimulation

EXPERIMENTAL

Parkinson's disease patients with insomnia receiving 40 Hz flicker light stimulation plus standard PD care.

Device: 40 Hz flicker light device

100 Hz flicker light stimulation

SHAM COMPARATOR

Parkinson's disease patients with insomnia receiving 100 Hz flicker light stimulation plus standard PD care.

Device: 100 Hz flicker light device

Interventions

40 Hz flicker light device 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.

40 Hz flicker light stimulation

100 Hz flicker light device 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.

100 Hz flicker light stimulation

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Parkinson's disease according to established clinical criteria (e.g., Movement Disorder Society criteria).
• Age between 50 and 75 years.
• Disease duration ≤ 10 years and Hoehn and Yahr stage ≤ 3 in the "on" state.
• Clinically significant insomnia, defined as Parkinson's Disease Sleep Scale-2 (PDSS-2) total score ≥ 18 points and/or meeting diagnostic criteria for insomnia.
• Stable antiparkinsonian medication regimen for at least 4 weeks prior to enrollment.
• Able and willing to comply with study procedures and provide written informed consent.

You may not qualify if:

• Secondary insomnia primarily due to severe systemic diseases or major psychiatric disorders (e.g., psychosis, severe depression or anxiety) or substance abuse.
• History of epilepsy, photosensitive seizures, photosensitive dermatitis, or other conditions in which flicker light stimulation is contraindicated.
• Severe visual impairment or eye diseases that would interfere with light stimulation or safety assessment.
• Unstable or severe medical conditions (e.g., uncontrolled cardiovascular, hepatic, renal, or endocrine disease) that, in the investigator's opinion, make participation unsafe.
• Participation in another interventional clinical trial within the past 3 months.
• Inability to complete study procedures or follow-up due to cognitive, physical, or social reasons.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead
• The Eye Hospital of Wenzhou Medical University: collaborator

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haochen Sun

  Jiangsu Province Nanjing Brain Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haochen Sun, MD

CONTACT

+86-025-82296261; 735690822@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 7, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12