Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Study Overview
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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.

Official Title
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A Randomized, Double-blind, Crossover, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Conditions
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Insomnia

Intervention / Treatment
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* Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation
* Device: Air inhalation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed of insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). 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. Signed informed consent form (ICF). Exclusion Criteria: Complicated with other sleep disorders (sleep apnea syndrome, narcolepsy, restless legs syndrome, nocturia, etc.); Complicated with serious heart, lung, liver or renal diseases or malignant tumor; History of mental illness; Drugs or substances abuse; Pregnant women, breast-feeding women or those with recent birth plans; Participants in other clinical trials within 1 month before the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d | Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation<br>* H2-O2 inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)<br>|
| Placebo Comparator: Control group<br>Air inhalation, 900ml/min, 2h/d | Device: Air inhalation<br>* Air inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks | This outcome reflects change of patients' sleep quality. | 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. | 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. | 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. | 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. | 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. | visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Hamilton Anxiety Scale (HAMA) score at 14 weeks | The HAMA is a widely used interview scale to measure the severity of anxiety. The HAMA score ranges from 0 to 56. The higher the HAMA score is, the worse the symptoms are. | Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week) | 
| Change from baseline in Hamilton Depression Scale-17 (HAMD-17) score at 14 weeks | The HAMD-17 is a test measuring the severity of depressive symptoms. The HAMA-17 score ranges from 0 to 52. The higher the HAMA score is, the worse the symptoms are. | Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week) | 
| Change from baseline in Mini-Mental State Examination (MMSE) score at 14 weeks | The MMSE is widely used to assess cognition. The MMSE score ranges from 0 to 30. The higher the HAMA score is, the better the cognitive function is. | Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week) | 
| Change from baseline in Montreal Cognitive Assessment (MOCA) score at 14 weeks | The MoCA is widely used to assess cognition. The HAMA-17 score ranges from 0 to 30. The higher the HAMA score is, the better the cognitive function is. | Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week) | 
| Change from baseline in C-reactive protein (CRP) at 10 weeks | This outcome reflects change of patients' serum inflammatory factor. | visit 1(baseline), visit 3(4th week), visit 6(10th week) | 
| Change from baseline in Interleukin-6 (IL-6) at 10 weeks | This outcome reflects change of patients' serum inflammatory factor. | visit 1(baseline), visit 3(4th week), visit 6(10th week) | 
| Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks | This outcome reflects change of patients' serum inflammatory factor. | visit 1(baseline), visit 3(4th week), visit 6(10th week) | 
| Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks | This outcome reflects change of patients' serum inflammatory factor. | visit 1(baseline), visit 3(4th week), visit 6(10th week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insomnia, Hydrogen-oxygen Mixed Gas