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Study on the Clinical Effect of the "Nine-Step Longevity Method" in Intervening in Insomnia with Difficulty Falling Asleep and the Mechanism of Functional Connectivity between fMRI and EEG

Study on the Clinical Effect of the "Nine-Step Longevity Method" in Intervening in Insomnia with Difficulty Falling Asleep and the Mechanism of Functional Connectivity between fMRI and EEG

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001653
Enrollment
Unknown
Registered
2026-07-06
Start date
2026-07-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

chronic insomnia

Interventions

observation group:Qigong intervention
control group:Insomnia Cognitive Behavioral Therapy

Sponsors

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic insomnia according to ICSD-3; (2) Age between 18 and 65 years, right-handed; (3) Pittsburgh Sleep Quality Index (PSQI) score >7, ISI score =8; (4) Chief complaint of difficulty falling asleep, sleep latency =30 minutes, occurring at least 3 times per week for a duration of =3 months; (5) Willing to participate in the study and able to provide informed consent.

Exclusion criteria

Exclusion criteria: (1) Suffering from other sleep disorders such as obstructive sleep apnea syndrome, narcolepsy or restless legs syndrome; (2) Having a clearly diagnosed central nervous system disease such as dementia, epilepsy, Alzheimer's disease, cognitive impairment, Parkinson's disease, depression, anxiety disorder, etc.; (3) In the acute stage of underlying diseases that may affect insomnia, such as diabetes, hypertension, coronary heart disease, chronic nephritis, chronic pain, etc.; (4) Pregnant women; (5) Having received the Yanzhuan Jiuzhuan method or CBT-I treatment in the past; (6) Long-term shift workers; (7) Those who are currently participating in other clinical trials and have not completed them.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index, PSQI;

Secondary

MeasureTime frame
Insomnia Severity Index, ISI;Pre-Sleep Arousal Scale, PSAS;Hospital Anxiety and Depression Scale, HADS;erceived Stress Scale, PSS;Hyperarousal Scale, HAS;Morningness-Eveningness Questionnaire, MEQ;Multidimensional Fatigue Inventory, MFI20;Gastrointestinal Symptom Rating Scale, GSRS;the 36-Item Short Form Health Survey, SF-36;Actigraphy;Peripheral Blood;Resting state functional magnetic resonance;Polysomnography monitoring throughout the night;Intestinal microbiota detection;sleep diary;

Countries

China

Contacts

Public ContactWang guimao

Shanghai municipal Hospital of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

wangguimao@shutcm.edu.cn13764628380

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Aug 10, 2026