Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

Not Applicable

• Conditions: Post-ischemic Stroke Insomnia
• Interventions: Other: ozone autohemotherapy

• 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

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-17
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-18
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-22
• Study Start: 2022-08-26
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• meet the diagnostic criteria for ischemic stroke; Insomnia quality index (ISI) score > 7 points

Exclusion Criteria

• 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

Arm && Interventions

Group	Intervention	Description
20-40ug/ml ozone	ozone autohemotherapy	ozone autohemotherapy

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