Status unknownNCT05248360Updated Dec 15, 2022

Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

An interventional study of Hydrogen-oxygen mixed gas(H2-O2) inhalation and Air inhalation in Insomnia, sponsored by Second Affiliated Hospital of Soochow University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-15.

Sponsored by Second Affiliated Hospital of Soochow University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Enrolling by invitation — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 40
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

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

Read the 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.

Conditions studied

Insomnia

Browse trials for

Sleep Initiation and Maintenance Disorders 1,856

Keywords

Insomnia
Hydrogen-oxygen Mixed Gas

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's planned enrollment of 40 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

Second Affiliated Hospital of Soochow University is the lead sponsor of 60 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 40 participants (estimated)

Study arms

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
Placebo comparator
Control group
Air inhalation, 900ml/min, 2h/d
Device: Air inhalation

Interventions

DeviceHydrogen-oxygen mixed gas(H2-O2) inhalation
H2-O2 inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)
DeviceAir inhalation
Air inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)

What researchers measure

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

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.
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 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.
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 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.
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 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.
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 C-reactive protein (CRP) at 10 weeks
This outcome reflects change of patients' serum inflammatory factor.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)

Study locations

1 site

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

References and documents

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. PubMed 26140821 ↗
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. PubMed 25747486 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05248360
Lead sponsor: Second Affiliated Hospital of Soochow University
Responsible party: Chun-Feng Liu (Professor, Second Affiliated Hospital of Soochow University) — Principal investigator
First posted: Feb 21, 2022
Start date: Oct 11, 2022
Primary completion: Sep 1, 2023 (estimated)
Completion: Dec 31, 2023 (estimated)
Last update: Dec 15, 2022

Study contacts

Chun-Feng Liu, MD

principal investigator · Second Affiliated Hospital of Soochow University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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