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Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease

NCT07299240 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-30

No results posted yet for this study

Summary

This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.

Conditions

Interventions

DEVICE

Remote ischemic conditioning device

An automated upper-limb cuff device is applied to one arm to induce brief episodes of limb ischemia and reperfusion. In the active RIC group, the cuff is inflated to a high pressure (approximately 200 mmHg) sufficient to occlude arterial blood flow, and then deflated repeatedly according to a pre-set program recommended by the manufacturer. RIC is performed twice daily for 7 consecutive days.

DEVICE

Sham remote ischemic conditioning

The same device and procedure are used as in the active RIC group, but the cuff is inflated only to a low pressure (approximately 60 mmHg) that does not occlude arterial blood flow. Sham RIC is performed twice daily for 7 consecutive days.

Sponsors & Collaborators

  • Jiangsu Province Nanjing Brain Hospital

    lead OTHER

Principal Investigators

  • Haochen Sun · Department of Neurology, the Affiliated Brain Hospital of Nanjing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07299240 on ClinicalTrials.gov