Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Not Applicable

• Conditions: Insomnia
• Interventions: Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation; Device: Air inhalation

• Registration Number: NCT05248360
• Lead Sponsor: Second Affiliated Hospital of Soochow University

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.

Study Timeline

• Study First Submitted: 2022-02-03
• Study First Submitted QC: 2022-02-16
• Study First Posted: 2022-02-21
• Study Start: 2022-10-11
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental group	Hydrogen-oxygen mixed gas(H2-O2) inhalation	Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d
Control group	Air inhalation	Air inhalation, 900ml/min, 2h/d

Primary Outcome Measures

Name	Time	Method
Change from baseline in sleep latency by PSG at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' sleep quality.
Change from baseline in wake time after sleep onset by PSG at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' sleep quality.
Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' sleep quality.
Change from baseline in total sleep time by PSG at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' sleep quality.
Change from baseline in Insomnia Severity Index (ISI) score at 14 weeks	visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)	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.
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 14 weeks	visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.
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)	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.
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)	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.
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)	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.
Change from baseline in Interleukin-6 (IL-6) at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' serum inflammatory factor.
Change from baseline in C-reactive protein (CRP) at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' serum inflammatory factor.
Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' serum inflammatory factor.
Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks	visit 1(baseline), visit 3(4th week), visit 6(10th week)	This outcome reflects change of patients' serum inflammatory factor.

Trial Locations

Locations (1)

Department of Neurology, Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China