Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

Sponsor

Mengmeng Chen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05508113

Collaborator

(none)

Enrollment

Arms

4.2

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-ischemic Stroke Insomnia	Other: ozone autohemotherapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

Effects of Ozone Autohemotherapy on Patients With Post-ischemic Stroke Insomnia

Anticipated Study Start Date :

Aug 26, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control No intervention was given to this group of patients
Experimental: 20-40ug/ml ozone ozone autohemotherapy	Other: ozone autohemotherapy After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion

Arm

Intervention/Treatment

No Intervention: Control

No intervention was given to this group of patients

Experimental: 20-40ug/ml ozone

ozone autohemotherapy

Other: ozone autohemotherapy

After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion

Outcome Measures

Primary Outcome Measures

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

brain-derived neurotrophic factor (BDNF) [2 weeks]
Detection of BDNF in serum of patients using Elisa kit

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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