Comorbid insomnia and sleep apnea
Conditions
Interventions
Sham group:Needling at Non-Acupoint, Non-Meridian
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18 to 75 years, regardless of gender; 2) Meet the diagnostic criteria for chronic insomnia and obstructive sleep apnea (OSA) established in this study; 3) Insomnia Severity Index (ISI) score > 10; 4) No intellectual abnormalities, able to understand the content of each scale and complete the assessment; 5) Agree to participate in this study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1)Polysomnography (PSG) shows an Apnea-Hypopnea Index (AHI) = 30 events/hour and/or a minimum blood oxygen saturation = 80% during sleep, and/or a periodic limb movement-related arousal index = 15 events/hour during sleep; 2)Presence of untreated restless legs syndrome or parasomnia disorders; 3)Presence of Central Disorders of Hypersomnolence such as narcolepsy; 4)Shift work within 2 weeks prior to screening, travel across > 2 time zones, or plans for shift work/travel across > 2 time zones during the study; or presence of circadian rhythm sleep-wake disorders; 5)Use of classic benzodiazepines (including estazolam, alprazolam, lorazepam, diazepam, oxazepam, clonazepam), psychostimulants from 2 weeks prior to screening or 5 half-lives of the corresponding drug (whichever is longer) until the end of the study treatment (i.e., the end of the safety follow-up phase); 6)Unstable use of other sedative-hypnotics, anxiolytics, antidepressants, or antipsychotics from 2 weeks prior to screening or 5 half-lives of the corresponding drug (whichever is longer) until the end of the study treatment (i.e., the end of the safety follow-up phase); 7)Previous diagnosis of one or more mental illnesses, including mania or manic episodes, schizophrenia, major depressive disorder with psychotic features, bipolar disorder, substance abuse, active major depressive episodes, or active and unstable mental illnesses within the past 6 months; 8)Heavy smoking (at least one pack per day) or caffeine intake = 600 mg/day; 9)Presence of unstable/major/acute diseases requiring hospitalization or surgery, or abnormalities within 1 month prior to screening that the investigator deems may affect the safety of study participants or interfere with study assessments; 10)Local skin or tissue infection at acupuncture points; 11)Pregnant or lactating patients, or those currently participating in other interventional clinical trials; 12)Participants deemed by the investigator as unlikely to comply with the protocol or unsuitable for the study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep Quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective Sleep Quality;Excessive Daytime Sleepiness and Fatigue Condition;Emotional Condition;Objective Sleep parameters; | — |
Countries
China
Contacts
Public ContactHuan YU
Huashan Hospital, Fudan University
Outcome results
None listed