Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder
- Conditions
- Post-ischemic Stroke Insomnia
- Registration Number
- NCT05508113
- Lead Sponsor
- Mengmeng Chen
- Brief Summary
The purpose of this study is to observe the efficacy and safety of ozonated autohemotherapy in patients of post-ischemic stroke insomnia and to explore its mechanism of action.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- meet the diagnostic criteria for ischemic stroke; Insomnia quality index (ISI) score > 7 points
- acute ischemic stroke; associated with failure of important organs or malignant tumor; patients with worsening condition, new cerebral infarction or secondary cerebral hemorrhage; with comprehension or cognitive impairment, unable to fully understand the scale and unable to cooperate with treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Insomnia severity index 2 weeks The Insomnia Severity Index Scale (ISI) will be used, which scale ranges from 0 to 28, with higher scores representing more severe insomnia. Specifically, 0-5 points represent excellent sleep quality, 6-10 points mean good sleep quality, 11-15 points indicate average sleep quality, and 16-21 points represent poor sleep quality.
Pittsburgh Sleep Quality Index 2 weeks The Pittsburgh Sleep Quality Index Scale (PSQI) will be used, which scale ranges from 0 to 21, with higher scores representing poorer sleep quality. In detail, 0-7 points represent insomnia of no clinical significance, 8-14 points mean sub-clinical insomnia, 15-21 points indicate moderate clinical insomnia, and 22-28 points represent severe clinical insomnia.
- Secondary Outcome Measures
Name Time Method brain-derived neurotrophic factor (BDNF) 2 weeks Detection of BDNF in serum of patients using Elisa kit