An interventional study of ozone autohemotherapy in Post-ischemic Stroke Insomnia, sponsored by Mengmeng Chen. Completed at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-09-04.
Sponsored by Mengmeng Chen · Not applicable, Interventional, and Supportive care
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 65 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →This is the only study on the registry with Mengmeng Chen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The inclusion criteria were as follows:
(1) age ≥18 years old; (2) diagnosis of ischemic stroke by cranial CT or MRI and other related imaging examinations; (3) Insomnia Severity Index (ISI) score > 7 points; (4) post-ischemic stroke insomnia; (5) sufficient cognitive function and communication ability to provide informed consent and perform the study protocol.
The exclusion criteria were as follows:
(1) G6PHD (glucose 6 phosphate dehydrogenase) deficiency; (2) pregnancy; (3) toxic diffuse goiter; (4) severe coagulation disorder; (5) the use of psychotropic medications (hypnotics, benzodiazepine, benzodiazepine agonists, antidepressants, or antipsychotics) for sleep.
basic pharmacological treatment (oral betahistine hydrochloride (8 mg every 8 hours) and aspirin (0.1 g every 24 hours) ), activities of daily living training, rehabilitation education, and other appropriate rehabilitation interventions.
SoC with ozone autohemotherapy
Other: ozone autohemotherapy
After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion
Insomnia severity index
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.
Time frame: 10 days
Pittsburgh Sleep Quality Index
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.
Time frame: 10 days
Blood cell counts
Time frame: 10 days
Blood lipid level
Time frame: 10 days
tumor necrosis factor α [TNF-α], interleukin 1β [IL-1β] and interleukin 10 [IL-10]), 5-hydroxytryptamine (5-HT), norepinephrine (NE), dopamine (DA), brain-derived neurotrophic factors (BDNF).
Detection of these factors in serum of patients using Elisa kit
Time frame: 10 days
Finger oxygen saturation
Time frame: 10 days
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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