NCT05248360

Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

A Randomized, Double-blind, Crossover, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia

Interventions

Type	Name	Description
DEVICE	Hydrogen-oxygen mixed gas(H2-O2) inhalation	H2-O2 inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)
DEVICE	Air inhalation	Air inhalation, 900ml/min, 2h/d \* 4 weeks (≥5 days/week)

Timeline

• Start date: 2022-10-11
• Primary completion: 2023-09-01
• Completion: 2023-12-31
• First posted: 2022-02-21
• Last updated: 2022-12-15

Locations

1 site across 1 country: China