Status:
UNKNOWN
Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Insomnia
Eligibility:
All Genders
18-80 years
Phase:
NA
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,...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05248360
Start Date
October 11 2022
End Date
December 31 2023
Last Update
December 15 2022
Active Locations (1)
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1
Department of Neurology, Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004