A Randomized, Double-blind, Crossover, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Insomnia
- Sponsor
- Second Affiliated Hospital of Soochow University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from baseline in sleep latency by PSG at 10 weeks
- Status
- Enrolling By Invitation
- Last Updated
- 3 years ago
Overview
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.
Investigators
Chun-Feng Liu
Professor
Second Affiliated Hospital of Soochow University
Eligibility Criteria
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
- •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.
Outcomes
Primary Outcomes
Change from baseline in sleep latency by PSG at 10 weeks
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- 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 Interleukin-6 (IL-6) at 10 weeks(visit 1(baseline), visit 3(4th week), visit 6(10th week))
- Change from baseline in C-reactive protein (CRP) at 10 weeks(visit 1(baseline), visit 3(4th week), visit 6(10th week))
- Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks(visit 1(baseline), visit 3(4th week), visit 6(10th week))
- Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks(visit 1(baseline), visit 3(4th week), visit 6(10th week))