Post-ischemic Stroke InsomniaNCT05508113
Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder
A study testing ozone autohemotherapy in people with Post-ischemic Stroke Insomnia, run by Mengmeng Chen at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Post-ischemic Stroke Insomnia
- What is being tested?
- ozone autohemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2022to 22 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
the Second Hospital of Jilin University
Changchun, Jilin, 130021
Huikang Hospital in Dehui city
Dehui, Jilin, 130021
About this study
Official title: Effects of Ozone Autohemotherapy on Patients With Post-ischemic Stroke Insomnia
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.
- Conditions
- Post-ischemic Stroke Insomnia
- Being tested
- ozone autohemotherapy
- Keywords
- Ischemic stroke, Insomnia, Ozone, Autohemotherapy
- Medical subject headings
- Ischemic Stroke, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ozone autohemotherapyOther
After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| SoC | No intervention | 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. |
| O3-AHT | Experimental | SoC with ozone autohemotherapy Receives: Other: ozone autohemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 days
Secondary outcomes (4)
Blood cell counts
Measured: 10 days
Blood lipid level
Measured: 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
Measured: 10 days
Finger oxygen saturation
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Aug 2022
- Primary completion30 May 2024
- Study completion22 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-ischemic Stroke InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mengmeng Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mengmeng Chen, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508113
- Sponsor's protocol ID
- 2022100
- Status last verified
- Sep 2026
- First submitted
- 17 Aug 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sekerdag E, Solaroglu I, Gursoy-Ozdemir Y. Cell Death Mechanisms in Stroke and Novel Molecular and Cellular Treatment Options. Curr Neuropharmacol. 2018;16(9):1396-1415. doi: 10.2174/1570159X16666180302115544.
PubMed 29512465Masan J, Sramka M, Rabarova D. The possibilities of using the effects of ozone therapy in neurology. Neuro Endocrinol Lett. 2021 Mar;42(1):13-21.
PubMed 33932964Kadir K, Syam Y, Yusuf S, Zainuddin M. Ozone Therapy on Reduction of Bacterial Colonies and Acceleration of Diabetic Foot Ulcer Healing. Home Healthc Now. 2020 Jul/Aug;38(4):215-220. doi: 10.1097/NHH.0000000000000889.
PubMed 32618780Martinez-Sanchez G, Delgado-Roche L, Diaz-Batista A, Perez-Davison G, Re L. Effects of ozone therapy on haemostatic and oxidative stress index in coronary artery disease. Eur J Pharmacol. 2012 Sep 15;691(1-3):156-62. doi: 10.1016/j.ejphar.2012.07.010. Epub 2012 Jul 13.
PubMed 22796450
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ozone Autohemotherapy on Patients With Post-ischemic Stroke Insomnia
- ClinicalTrials.gov ID
- NCT05508113
- Acronym / sponsor ID
- 2022100
- Conditions
- Post-ischemic Stroke Insomnia
- Keywords
- Ischemic stroke, Insomnia, Ozone, Autohemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Mengmeng ChenUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 22 Jun 2024 (actual)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SoC | No intervention | –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. |
| O3-AHT | Experimental | Other: ozone autohemotherapySoC with ozone autohemotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ozone autohemotherapyAfter autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion | Other | O3-AHT |
Primary outcome
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.
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.
4 secondary outcomes
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).
Time frame: 10 days
Finger oxygen saturation
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 29512465Sekerdag E, Solaroglu I, Gursoy-Ozdemir Y. Cell Death Mechanisms in Stroke and Novel Molecular and Cellular Treatment Options. Curr Neuropharmacol. 2018;16(9):1396-1415. doi: 10.2174/1570159X16666180302115544.
- Background: PubMed 33932964Masan J, Sramka M, Rabarova D. The possibilities of using the effects of ozone therapy in neurology. Neuro Endocrinol Lett. 2021 Mar;42(1):13-21.
- Background: PubMed 32618780Kadir K, Syam Y, Yusuf S, Zainuddin M. Ozone Therapy on Reduction of Bacterial Colonies and Acceleration of Diabetic Foot Ulcer Healing. Home Healthc Now. 2020 Jul/Aug;38(4):215-220. doi: 10.1097/NHH.0000000000000889.
- Background: PubMed 22796450Martinez-Sanchez G, Delgado-Roche L, Diaz-Batista A, Perez-Davison G, Re L. Effects of ozone therapy on haemostatic and oxidative stress index in coronary artery disease. Eur J Pharmacol. 2012 Sep 15;691(1-3):156-62. doi: 10.1016/j.ejphar.2012.07.010. Epub 2012 Jul 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ozone autohemotherapy in people with Post-ischemic Stroke Insomnia, run by Mengmeng Chen at 2 sites in China.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity index (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.