NCT05508113

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

August 26, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

August 17, 2022

Last Update Submit

August 18, 2022

Conditions

Post-ischemic Stroke Insomnia

Keywords

Ischemic strokeInsomniaOzone Autohemotherapy

Outcome Measures

Primary Outcomes (2)

  • 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.

    2 weeks

  • 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.

    2 weeks

Secondary Outcomes (1)

  • brain-derived neurotrophic factor (BDNF)

    2 weeks

Study Arms (2)

Control

NO INTERVENTION

No intervention was given to this group of patients

20-40ug/ml ozone

EXPERIMENTAL

ozone autohemotherapy

Other: ozone autohemotherapy

Interventions

ozone autohemotherapyOTHER

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

20-40ug/ml ozone

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • meet the diagnostic criteria for ischemic stroke; Insomnia quality index (ISI) score \> 7 points

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29512465BACKGROUND

  • Masan 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.

    PMID: 33932964BACKGROUND

  • Kadir 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.

    PMID: 32618780BACKGROUND

  • Martinez-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.

    PMID: 22796450BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Central Study Contacts

Lijing Zhao, Doctor

CONTACT

13756281155zhao_lj@jlu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 17, 2022

First Posted

August 19, 2022

Study Start

August 26, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share