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Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

Primary Purpose

Post-ischemic Stroke Insomnia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ozone autohemotherapy
Sponsored by
Mengmeng Chen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post-ischemic Stroke Insomnia focused on measuring Ischemic stroke, Insomnia, Ozone Autohemotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    20-40ug/ml ozone

    Arm Description

    No intervention was given to this group of patients

    ozone autohemotherapy

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    brain-derived neurotrophic factor (BDNF)
    Detection of BDNF in serum of patients using Elisa kit

    Full Information

    First Posted
    August 17, 2022
    Last Updated
    August 18, 2022
    Sponsor
    Mengmeng Chen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05508113
    Brief Title
    Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder
    Official Title
    Effects of Ozone Autohemotherapy on Patients With Post-ischemic Stroke Insomnia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 26, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mengmeng Chen

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-ischemic Stroke Insomnia
    Keywords
    Ischemic stroke, Insomnia, Ozone Autohemotherapy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    No intervention was given to this group of patients
    Arm Title
    20-40ug/ml ozone
    Arm Type
    Experimental
    Arm Description
    ozone autohemotherapy
    Intervention Type
    Other
    Intervention Name(s)
    ozone autohemotherapy
    Intervention Description
    After autologous blood is mixed with ozone in vitro, the blood is injected into the patient through intravenous infusion
    Primary Outcome Measure Information:
    Title
    Insomnia severity index
    Description
    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.
    Time Frame
    2 weeks
    Title
    Pittsburgh Sleep Quality Index
    Description
    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.
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    brain-derived neurotrophic factor (BDNF)
    Description
    Detection of BDNF in serum of patients using Elisa kit
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lijing Zhao, Doctor
    Phone
    13756281155
    Email
    zhao_lj@jlu.edu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29512465
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    33932964
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32618780
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    22796450
    Citation
    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.
    Results Reference
    background

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    Ozone Autohemotherapy for Ischemic Stroke Sleep Disorder

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