Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Insomnia
• Intervention / Treatment: Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation; Device: Air inhalation

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215004
      • Department of Neurology, Second Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; H2-O2 inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)
Placebo Comparator: Control group; Air inhalation, 900ml/min, 2h/d	Device: Air inhalation; Air inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Soochow University
• Investigators: Principal Investigator: Chun-Feng Liu, MD, Second Affiliated Hospital of Soochow University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Insomnia; Hydrogen-oxygen Mixed Gas
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: JD-LK-2021-100-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No