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Completed

NCT Number: NCT05508113

Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

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.

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Key information

Conditions

Post-ischemic Stroke Insomnia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Ischemic Stroke Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stroke Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Second Hospital of Jilin University, Changchun, Jilin, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ozone autohemotherapy

Other

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

Primary outcomes

  1. Insomnia severity index

    Time frame: 10 days

    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.

  2. Pittsburgh Sleep Quality Index

    Time frame: 10 days

    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 outcomes

  1. Blood cell counts

    Time frame: 10 days

  2. Blood lipid level

    Time frame: 10 days

  3. 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).

    Time frame: 10 days

    Detection of these factors in serum of patients using Elisa kit

  4. Finger oxygen saturation

    Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Mengmeng Chen

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2022
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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