Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05248360
• Other study ID #: JD-LK-2021-100-03
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 11, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Second Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Hydrogen-oxygen mixed gas(H2-O2) inhalation
H2-O2 inhalation, 900ml/min, 2h/d * 4 weeks (=5 days/week)
• Air inhalation
Air inhalation, 900ml/min, 2h/d * 4 weeks (=5 days/week)

Locations

Country	Name	City	State
China	Department of Neurology, Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Change from baseline in Interleukin-1ß ( IL-1ß) at 10 weeks	This outcome reflects change of patients' serum inflammatory factor.	visit 1(baseline), visit 3(4th week), visit 6(10th week)
Secondary	Change from baseline in tumor necrosis factor-a (TNF-a) at 10 weeks	This outcome reflects change of patients' serum inflammatory factor.	visit 1(baseline), visit 3(4th week), visit 6(10th week)