Can Ozone-Infused blood ease sleeplessness after a stroke?

NCT ID NCT05508113

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests whether ozone autohemotherapy, a procedure where a person's blood is mixed with ozone and put back into their body, can improve sleep in people who have insomnia after an ischemic stroke. Researchers will measure sleep quality and look at blood markers of inflammation and brain chemicals to see if the therapy helps and how it might work. The study includes adults who had an ischemic stroke and report poor sleep.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ozone autohemotherapy
What this could lead to
If it works, this could offer a new way to ease insomnia in stroke survivors, potentially improving their recovery and quality of life.
What could go wrong
This is a small, early-stage trial, so the treatment may not prove effective or safe. Ozone therapy carries risks like infection or allergic reactions, and its benefits for sleep are not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

65 people

The number who actually took part.

Started

Aug 2022

Finished

Jun 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

insomnia Ischemic Stroke

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Huikang Hospital in Dehui city

    Dehui, Jilin, 130021, China

  • the Second Hospital of Jilin University

    Changchun, Jilin, 130021, China