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The purpose of this study is to evaluate the efficacy and safety of hydrogen-oxygen mixed gas inhalation in the treatment of insomnia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Hydrogen-oxygen mixed gas(H2-O2, 66.6% hydrogen, 33.3% oxygen) inhalation, 900ml/min, 2h/d |
|
| Control group | Placebo Comparator | Air inhalation, 900ml/min, 2h/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrogen-oxygen mixed gas(H2-O2) inhalation | Device | H2-O2 inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in sleep efficiency by polysomnography (PSG) at 10 weeks | 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 | 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 | 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 | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Visit 1(baseline), visit 3(4th week), visit 4(6th week), visit 6(10th week), visit 7(14th week) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun-Feng Liu, MD | Second Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26140821 | Background | 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. | |
| 25747486 | Background | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Air inhalation | Device | Air inhalation, 900ml/min, 2h/d * 4 weeks (≥5 days/week) |
|
| 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. |
| 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 | 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 | 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 | 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 | 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 | 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 | This outcome reflects change of patients' serum inflammatory factor. | visit 1(baseline), visit 3(4th week), visit 6(10th week) |
| D001523 |
| Mental Disorders |