Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Soochow University

Status: Invitation-only

Conditions: Insomnia

Treatments: Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation; Device: Air inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT05248360

JD-LK-2021-100-03

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

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

Treatment:

Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation

Control group

Placebo Comparator group

Description:

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

Treatment:

Device: Air inhalation