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The Safety and Feasibility of Remote Ischemic Conditioning to Excessive daytime sleepiness in patients with Parkinson's disease.

The Safety and Feasibility of Remote Ischemic Conditioning to Excessive daytime sleepiness in patients with Parkinson's disease. - The Safety and Feasibility of RIC to EDS in patients with Parkinson's disease.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058430
Enrollment
Unknown
Registered
2022-04-09
Start date
2022-04-01
Completion date
Unknown
Last updated
2024-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

RIC group:Electronic tourniquets will be placed on both arms. Participants in the intervention group will inflate the cuff to 200 mmHg for 5 minutes after five cycles, and then deflate it for 5 minute
Control group(sham-RIC group):Electronic tourniquets will be placed on both arms. Participants in the intervention group will inflate the cuff to 60 mmHg for 5 minutes after five cycles, and then defl

Sponsors

Beijing Luhe Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Parkinson's disease patients diagnosed according to MDS clinical diagnostic criteria for Parkinson's disease; 2. Age 18-90 years old; 3. The patient's ESS score >=10; 4. The patient's vital signs were stable; 5. Written informed consent provided by the participant or legally authorized representative.

Exclusion criteria

Exclusion criteria: 1. Contraindication of ischemic conditioning (such as severe soft tissue injury, fracture and peripheral vascular disease of both upper limbs); 2. The patients' compliance is poor and follow-up cannot be completed.; 3. Life expectancy <=1 year; 4. Serious diseases such as lung, liver, and kidney are not controlled and stable; 5. Coagulation dysfunction or active bleeding; 6. Complicated with acute coronary syndrome or severe arrhythmia; 7. Pregnant or nursing patients; 8. Participating in another ongoing clinical trial within 30 days before the study is included.

Design outcomes

Primary

MeasureTime frame
Any serious RIC-related adverse events;Epworth sleepiness score (ESS);Pittsburgh sleep quality index, PSQI;Parkinson's Disease Sleep Scale (PDSS-2);Parkinson's Disease Questionnaire (PDQ-39);

Countries

China

Contacts

Public ContactQiling Ji

Beijing Luhe Hospital, Capital Medical University

jiqiling7313@163.com+86 13810383421

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026