NCT07323121Recruiting
40 Hz Flickering for Insomnia in Parkinson's Disease
Randomized, Single-blind, Controlled Study of 40 Hz Flickering Stimulation for Insomnia and Other Non-motor Symptoms in Patients With Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 11 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Jiangsu Province Nanjing Brain Hospital
- Diseases
- Parkinson disease
- NCT number
- NCT07323121
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jan 2026 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 50 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.