Insomnia
Conditions
Interventions
Sponsors
Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: Aged between 18 and 65 years (inclusive of 18 exclusive of 65) regardless of gender(paradoxical insomnia group) 2: Meet the diagnostic criteria for chronic insomnia(paradoxical insomnia group) 3: Insomnia Severity Index (ISI) score > 10(paradoxical insomnia group) 4: Polysomnography (PSG) indicates an objective total sleep time > 6 hours while the sleep questionnaire suggests a subjective total sleep time shorter than the objective sleep time with a difference of > 60 minutes(paradoxical insomnia group) 5: Have never received acupuncture treatment(paradoxical insomnia group) 6: Capable of good communication with the researchers able to understand the study requirements and have the ability to complete the clinical study(paradoxical insomnia group) 7: Aged between 18 and 65 years (inclusive of 18 exclusive of 65) regardless of gender(Healthy Controls) 8: No complaints of sleep difficulties(Healthy Controls) 9: Insomnia Severity Index (ISI) score 6 hours with the sleep questionnaire showing a subjective total sleep time within 30 minutes of the objective total sleep time(Healthy Controls) 11: Capable of good communication with the researchers able to understand the study requirements and have the ability to complete the clinical study(Healthy Controls)
Exclusion criteria
Exclusion criteria: 1: PSG indicates an Apnea-Hypopnea Index (AHI) = 15 events/hour or a Periodic Limb Movement Index (PLMI) = 15 events/hour; 2: Presence of restless legs syndrome sleep-wake circadian rhythm disorders parasomnias or narcolepsy; 3: Night shift work within 2 weeks prior to screening or planned night shift work during the study period; 4: Travel across more than 2 time zones within 2 weeks prior to screening or planned travel across more than 2 time zones during the study period; 5: Use of active substances (including over-the-counter medications and herbal remedies) within 2 weeks prior to screening or within 5 half-lives of the substance whichever is longer until the end of the study (i.e. the completion of the safety follow-up phase); 6: Diagnosis of alcohol or substance use disorder within 2 years prior to screening or inability to abstain from alcohol for at least 3 consecutive days; 7: Heavy smoking (at least one pack per day) or caffeine intake = 600 mg/day; 8: Presence of unstable medical conditions significant illness acute illness or any abnormalities within 1 month prior to screening that in the investigator's opinion may compromise the participant's safety or interfere with study assessments; 9: Localized skin or tissue infection at acupuncture points. Add an additional exclusion criterion for research participants undergoing fMRI examinations: 10: Individuals with contraindications for cranial magnetic resonance imaging such as the presence of metal implants in the body or intracranial organic lesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale;Beck Depression Inventory;Beck Anxiety Inventory;sleep diary;FS-14;Pittsburgh Sleep Quality Index; | — |
Countries
China
Contacts
Public ContactCONG FU
Huashan Hospital Fudan University
Outcome results
None listed