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Study on the Correlation and Mechanisms Between Functional MRI Changes and Sleep Structure in Patients with Insomnia Comorbid with Obstructive Sleep Apnea

Study on the Correlation and Mechanisms Between Functional MRI Changes and Sleep Structure in Patients with Insomnia Comorbid with Obstructive Sleep Apnea

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500095809
Enrollment
Unknown
Registered
2025-01-13
Start date
2024-03-22
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

insomnia,obstructive sleep apnea

Interventions

healthy people group:none
COMISA-PAP treatment:none
COMISA-no PAP treatment:none

Sponsors

Wuxi people’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.With consent and a signed informed consent form, the participant agrees to complete the study as required by the protocol. 2.Age 18-70 years old, male and female; 3.In accordance with the Chinese Medical Association "Obstructive sleep apnea hypopnea diagnosis and therapeutic criteria", confirmed by polysomnography monitoring, and sleep apnea hypopnea index (AHI) AHI =5 times /h, Minimum oxygen saturation at night = 3 nights per week, plus significant daytime disturbance or distress in at least one area, under the conditions of adequate sleep time and appropriate sleep environment; 5.No mental illness, hearing and speech impairment, no history of sedatives and drug or alcohol dependence. 6.Specifically, patients in the insomnia group must meet criteria 1), 2), 4), and 5); patients in the OSA group must meet criteria 1), 2), 3), and 5); patients in the COMISA group must meet criteria 1), 2), 3), 4), and 5); and participants in the healthy control group must meet criteria 1), 2), and 5).

Exclusion criteria

Exclusion criteria: 1.Diagnosed with central or mixed sleep apnea, with central or mixed apnea accounting for =50%, or diagnosed with Cheyne-Stokes respiration. 2.Diagnosed with obesity hypoventilation syndrome or daytime hypercapnia. 3.Presence of respiratory or neuromuscular disorders deemed by the investigator to potentially interfere with study outcomes. 4.Acute infection, trauma, or major surgery within one month prior to screening. 5.Acute cardiovascular or cerebrovascular events within six months prior to screening. 6.History of malignant tumors within five years prior to screening, excluding carcinoma in situ. 7.Known or suspected history of substance abuse and/or alcoholism. 8.Presence or suspicion of severe depression, bipolar disorder, schizophrenia, suicidal tendencies, or other significant psychiatric disorders. 9.Inability to undergo cranial magnetic resonance imaging (MRI) due to physiological or psychological factors. 10.Use of intravenous glucocorticoids or stimulants such as modafinil within 14 days prior to screening. 11.Inability to complete questionnaire assessments.

Design outcomes

Primary

MeasureTime frame
cerebral magnetic resonance imaging (MRI);PSG;

Countries

China

Contacts

Public ContactZhang Yunyun

Wuxi people’s Hospital

zhangyunyun026133@126.com+86 18851515860

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 19, 2026