---
title: Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder
nct_id: NCT05508113
overall_status: UNKNOWN
phase: NA
sponsor: Mengmeng Chen
study_type: INTERVENTIONAL
primary_condition: Post-ischemic Stroke Insomnia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05508113.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05508113"
ct_last_update_post_date: 2022-08-22
last_seen_at: "2026-05-12T06:08:16.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

**Official Title:** Effects of Ozone Autohemotherapy on Patients With Post-ischemic Stroke Insomnia

**NCT ID:** [NCT05508113](https://clinicaltrials.gov/study/NCT05508113)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Mengmeng Chen
- **Conditions:** Post-ischemic Stroke Insomnia
- **Start Date:** 2022-08-26
- **Completion Date:** 2022-12-31
- **CT.gov Last Update:** 2022-08-22

## 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.

## Eligibility

- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Control** (NO_INTERVENTION) — No intervention was given to this group of patients
- **20-40ug/ml ozone** (EXPERIMENTAL) — ozone autohemotherapy

## Interventions

- **ozone autohemotherapy** (OTHER) — After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion

## Primary Outcomes

- **Insomnia severity index** _(time frame: 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** _(time frame: 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 Outcomes

- **brain-derived neurotrophic factor (BDNF)** _(time frame: 2 weeks)_

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05508113.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05508113*  
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