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Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

NCT ID: NCT05248360

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-11

Study Completion Date

2023-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas inhalation in the treatment of insomnia.

Detailed Description

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This ia a randomized, double-blind, crossover, placebo-controlled Study. The purpose is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas(H2-O2) inhalation in the treatment of insomnia, and explore the possible mechanism by detecting the changes of serum inflammatory factors (CRP, IL-6, IL-1β, TNF-α) levels, so as to seek an effective therapy for insomnia.

Conditions

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Insomnia

Keywords

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Insomnia Hydrogen-oxygen Mixed Gas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental group

Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d

Group Type EXPERIMENTAL

Hydrogen-oxygen mixed gas(H2-O2) inhalation

Intervention Type DEVICE

H2-O2 inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)

Control group

Air inhalation, 900ml/min, 2h/d

Group Type PLACEBO_COMPARATOR

Air inhalation

Intervention Type DEVICE

Air inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)

Interventions

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Hydrogen-oxygen mixed gas(H2-O2) inhalation

H2-O2 inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)

Intervention Type DEVICE

Air inhalation

Air inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).
2. No use of sleep medications within the preceding 2 weeks, or a stable dose of only one sedative hypnotic medicine for at least 1 month before the enrollment and remain unchanged throughout the course of the study.
3. Signed informed consent form (ICF).

Exclusion Criteria

1. Complicated with other sleep disorders (sleep apnea syndrome, narcolepsy, restless legs syndrome, nocturia, etc.);
2. Complicated with serious heart, lung, liver or renal diseases or malignant tumor;
3. History of mental illness;
4. Drugs or substances abuse;
5. Pregnant women, breast-feeding women or those with recent birth plans;
6. Participants in other clinical trials within 1 month before the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital of Soochow University

OTHER

Sponsor Role lead

Responsible Party

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Chun-Feng Liu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chun-Feng Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Soochow University

Locations

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Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

Countries

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China

References

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Irwin MR, Olmstead R, Carroll JE. Sleep Disturbance, Sleep Duration, and Inflammation: A Systematic Review and Meta-Analysis of Cohort Studies and Experimental Sleep Deprivation. Biol Psychiatry. 2016 Jul 1;80(1):40-52. doi: 10.1016/j.biopsych.2015.05.014. Epub 2015 Jun 1.

Reference Type BACKGROUND
PMID: 26140821 (View on PubMed)

Ohta S. Molecular hydrogen as a novel antioxidant: overview of the advantages of hydrogen for medical applications. Methods Enzymol. 2015;555:289-317. doi: 10.1016/bs.mie.2014.11.038. Epub 2015 Jan 21.

Reference Type BACKGROUND
PMID: 25747486 (View on PubMed)

Other Identifiers

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JD-LK-2021-100-03

Identifier Type: -

Identifier Source: org_study_id