Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

NCT05248360 | Unknown DMC

• 1 other identifier: JD-LK-2021-100-03
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Insomnia

Keywords

Insomnia; Hydrogen-oxygen Mixed Gas

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Change from baseline in Hamilton Anxiety Scale (HAMA) score at 14 weeks

  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

  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

  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

  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

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Device: Air inhalation

Interventions

Hydrogen-oxygen mixed gas(H2-O2) inhalation DEVICE

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

Experimental group

Air inhalation DEVICE

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

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

Study Sites (1)

Department of Neurology, Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215004, China

Location

Related Publications (2)

• 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.

  PMID: 26140821 BACKGROUND

• 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.

  PMID: 25747486 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Chun-Feng Liu, MD

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 3, 2022
• First Posted: February 21, 2022
• Study Start: October 11, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 31, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)