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Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

Primary Purpose

Insomnia

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Hydrogen-oxygen mixed gas(H2-O2) inhalation
Air inhalation
Sponsored by
Second Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Hydrogen-oxygen Mixed Gas

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology, Second Affiliated Hospital of Soochow University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d

Air inhalation, 900ml/min, 2h/d

Outcomes

Primary Outcome Measures

Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks
This outcome reflects change of patients' sleep quality.
Change from baseline in total sleep time by PSG at 10 weeks
This outcome reflects change of patients' sleep quality.
Change from baseline in sleep latency by PSG at 10 weeks
This outcome reflects change of patients' sleep quality.
Change from baseline in wake time after sleep onset by PSG at 10 weeks
This outcome reflects change of patients' sleep quality.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
Change from baseline in C-reactive protein (CRP) at 10 weeks
This outcome reflects change of patients' serum inflammatory factor.
Change from baseline in Interleukin-6 (IL-6) at 10 weeks
This outcome reflects change of patients' serum inflammatory factor.
Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks
This outcome reflects change of patients' serum inflammatory factor.
Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks
This outcome reflects change of patients' serum inflammatory factor.

Full Information

First Posted
February 3, 2022
Last Updated
December 14, 2022
Sponsor
Second Affiliated Hospital of Soochow University
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1. Study Identification

Unique Protocol Identification Number
NCT05248360
Brief Title
Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 11, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Hydrogen-oxygen Mixed Gas

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Air inhalation, 900ml/min, 2h/d
Intervention Type
Device
Intervention Name(s)
Hydrogen-oxygen mixed gas(H2-O2) inhalation
Intervention Description
H2-O2 inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)
Intervention Type
Device
Intervention Name(s)
Air inhalation
Intervention Description
Air inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week)
Primary Outcome Measure Information:
Title
Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks
Description
This outcome reflects change of patients' sleep quality.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in total sleep time by PSG at 10 weeks
Description
This outcome reflects change of patients' sleep quality.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in sleep latency by PSG at 10 weeks
Description
This outcome reflects change of patients' sleep quality.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in wake time after sleep onset by PSG at 10 weeks
Description
This outcome reflects change of patients' sleep quality.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in Insomnia Severity Index (ISI) score at 14 weeks
Description
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.
Time Frame
visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Title
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) score at 14 weeks
Description
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.
Time Frame
visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Secondary Outcome Measure Information:
Title
Change from baseline in Hamilton Anxiety Scale (HAMA) score at 14 weeks
Description
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.
Time Frame
Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Title
Change from baseline in Hamilton Depression Scale-17 (HAMD-17) score at 14 weeks
Description
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.
Time Frame
Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Title
Change from baseline in Mini-Mental State Examination (MMSE) score at 14 weeks
Description
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.
Time Frame
Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Title
Change from baseline in Montreal Cognitive Assessment (MOCA) score at 14 weeks
Description
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.
Time Frame
Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week)
Title
Change from baseline in C-reactive protein (CRP) at 10 weeks
Description
This outcome reflects change of patients' serum inflammatory factor.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in Interleukin-6 (IL-6) at 10 weeks
Description
This outcome reflects change of patients' serum inflammatory factor.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in Interleukin-1β ( IL-1β) at 10 weeks
Description
This outcome reflects change of patients' serum inflammatory factor.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)
Title
Change from baseline in tumor necrosis factor-α (TNF-α) at 10 weeks
Description
This outcome reflects change of patients' serum inflammatory factor.
Time Frame
visit 1(baseline), visit 3(4th week), visit 6(10th week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Feng Liu, MD
Organizational Affiliation
Second Affiliated Hospital of Soochow University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Second Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26140821
Citation
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.
Results Reference
background
PubMed Identifier
25747486
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.
Results Reference
background

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Hydrogen-oxygen Mixed Gas in the Treatment of Insomnia

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