Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Second Affiliated Hospital of Soochow University40 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Insomnia

Interventions

Hydrogen-oxygen mixed gas(H2-O2) inhalationDEVICE

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

Air inhalationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Outcomes

Primary Outcomes

Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks

This outcome reflects change of patients' sleep quality.

Time frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)

Change from baseline in total sleep time by PSG at 10 weeks

This outcome reflects change of patients' sleep quality.

Time frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)

Change from baseline in sleep latency by PSG at 10 weeks

This outcome reflects change of patients' sleep quality.

Time frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)

Change from baseline in wake time after sleep onset by PSG at 10 weeks

This outcome reflects change of patients' sleep quality.

Time frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)

Change from baseline in Insomnia Severity Index (ISI) score at 14 weeks

The ISI is widely used to measure the severity of Insomnia. The ISI score ranges from 0 to 28. The higher the ISI score is, the worse the symptoms are.

Time frame: visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)

Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 14 weeks

The PSQI is widely used to measure sleep quality. The PSQI score ranges from 0 to 21. The higher the PSQI score is, the worse the sleep quality is.

Time frame: visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)

Secondary Outcomes

Data from ClinicalTrials.gov

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