Post-ischemic Stroke Insomnia
Conditions
Keywords
Ischemic stroke, Insomnia, Ozone, Autohemotherapy
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.
Interventions
OTHERozone autohemotherapy
After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion
Sponsors
Mengmeng Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia severity index | 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. |
| Pittsburgh Sleep Quality Index | 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
| Measure | Time frame | Description |
|---|---|---|
| Blood cell counts | 10 days | — |
| Blood lipid level | 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). | 10 days | Detection of these factors in serum of patients using Elisa kit |
| Finger oxygen saturation | 10 days | — |
Countries
China
Outcome results
None listed