Clinical trial NCT05248360: Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia
Official title: A Randomized, Double-blind, Crossover, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Hydrogen-oxygen Mixed Gas
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2022-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in total sleep time by PSG at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in sleep latency by PSG at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in wake time after sleep onset by PSG at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in Insomnia Severity Index (ISI) score at 14 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
measure: Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 14 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Secondary outcomes:
measure: Change from baseline in Hamilton Anxiety Scale (HAMA) score at 14 weeks
timeFrame: Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
measure: Change from baseline in Hamilton Depression Scale-17 (HAMD-17) score at 14 weeks
timeFrame: Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
measure: Change from baseline in Mini-Mental State Examination (MMSE) score at 14 weeks
timeFrame: Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
measure: Change from baseline in Montreal Cognitive Assessment (MOCA) score at 14 weeks
timeFrame: Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
measure: Change from baseline in C-reactive protein (CRP) at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in Interleukin-6 (IL-6) at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
measure: Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks
timeFrame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Department of Neurology, Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Chun-Feng Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.