Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

December 14, 2022 updated by: Chun-Feng Liu, Second Affiliated Hospital of Soochow University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215004
        • Department of Neurology, Second Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d
Device: Hydrogen-oxygen mixed gas(H2-O2) inhalation
H2-O2 inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)
Placebo Comparator: Control group
Air inhalation, 900ml/min, 2h/d
Device: Air inhalation
Air inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
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.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
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.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
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.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
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.
visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
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.
visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in Hamilton Anxiety Scale (HAMA) 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 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)
Change from baseline in Hamilton Depression Scale-17 (HAMD-17) 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 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)
Change from baseline in Mini-Mental State Examination (MMSE) 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 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)
Change from baseline in Montreal Cognitive Assessment (MOCA) 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 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)
Change from baseline in C-reactive protein (CRP) at 10 weeks
Time Frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
This outcome reflects change of patients' serum inflammatory factor.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Change from baseline in Interleukin-6 (IL-6) at 10 weeks
Time Frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
This outcome reflects change of patients' serum inflammatory factor.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks
Time Frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
This outcome reflects change of patients' serum inflammatory factor.
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks
Time Frame: visit 1(baseline), visit 3(4th week), visit 6(10th week)
This outcome reflects change of patients' serum inflammatory factor.
visit 1(baseline), visit 3(4th week), visit 6(10th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital of Soochow University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chun-Feng Liu, MD, Second Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 11, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JD-LK-2021-100-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings