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Oxygen and Sleep Exploratory Study

Oxygen and Sleep Exploratory Study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072452
Enrollment
Unknown
Registered
2023-06-14
Start date
2023-06-15
Completion date
Unknown
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Interventions

Chronic insomnia group 1:Conventional drug therapy
Chronic insomnia group 2:oxygen therapy + Conventional drug therapy
Depression comorbid insomnia group 1:Conventional drug therapy
Depression comorbid insomnia group 2:Oxygen therapy + Conventional drug therapy
Generalized anxiety disorder comorbid insomnia group 1:Conventional drug therapy
Generalized anxiety disorder comorbid insomnia group 2:Oxygen therapy + Conventional drug therapy
Health control group:None

Sponsors

The Second Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients with chronic insomnia (n1=60) ?Meet the diagnostic criteria for chronic insomnia in ICSD-3; ?Age between 18 and 65 years old; ?Chinese, Han nationality; ?Understand the research content and sign the informed consent form. (2) Major depressive disorder comorbid with insomnia (n2=60) ?Meet the diagnostic criteria for chronic insomnia in ICSD-3 and major depressive disorder in DSM-V; ?Age between 18 and 65 years old; ?Chinese, Han nationality; ?Understand the research content and sign the informed consent form. (3) Patients with generalized anxiety disorder and insomnia (n3=60) ?Meet the diagnostic criteria for chronic insomnia in ICSD-3 and generalized anxiety disorder in DSM-V; ?Age between 18 and 65 years old; ?Chinese, Han nationality; ?Understand the research content and sign the informed consent form. (4) Healthy control group (n0=30) Inclusion criteria: ?No sleep disturbance and mental illness; ?Age between 18 and 65 years old; ?Chinese, Han nationality; ?Understand the research content and sign the informed consent form.

Exclusion criteria

Exclusion criteria: ? There are serious physical diseases that affect this study; ? Comorbidity with other mental disorders (such as schizophrenia, post-traumatic stress disorder, etc.); ? Comorbidity with other sleep disorders (such as sleep apnea syndrome (AHI>15 ), sleep-related movement disorders (PLMS index > 15); ? alcohol, drug and other substance abuse in the past year; ? obvious suicidal ideation or suicide attempt or Hamilton Depression Scale 24 suicide item score = 2; ? visual acuity or It is difficult to cooperate with the completion of the study with corrected vision; ?Cannot communicate normally due to language and other problems; ?Participated in or is currently participating in clinical trials related to this study within 3 months; ?Cannot cooperate with researchers due to various other reasons.

Design outcomes

Primary

MeasureTime frame
Event-related potential;Polysomnogram;

Countries

China

Contacts

Public ContactLiwen Tan

The Second Xiangya Hospital of Central South University

tanliwen@csu.edu.cn+86 138 7487 0034

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 23, 2026