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Completed
NCT07788547
Traditional Chinese Medicine Herbal Sachet for Insomnia in Older Adults
Conditions: Sleep Initiation and Maintenance Disorders
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 154
Sponsor: Macao Polytechnic University
Location: Baishan Elderly Apartment Qingdao Shandong
Summary
The goal of this clinical trial was to determine whether nightly exposure to a Traditional Chinese Medicine herbal sachet could reduce insomnia symptoms and improve sleep quality in adults aged 60 years or older. Participants residing in five community-based integrated medical and elderly-care facilities in Qingdao, China, were assigned by chance to receive either the herbal sachet or a placebo sachet. Participants placed the assigned sachet within 30 centimeters of the head from 7:00 p.m. to 8:00 a.m. each night for eight weeks. Insomnia symptoms and sleep quality were assessed using the Athens Insomnia Scale and Pittsburgh Sleep Quality Index. Adverse reactions were monitored throughout the intervention
Eligibility Criteria
Inclusion Criteria:
* Age 60 years or older.
* Athens Insomnia Scale (AIS) total score of 6 or higher.
* In generally good health or with a stable medical condition, with no major surgery, emergency event, or serious trauma during the previous 6 months.
* Able to remain at the same residential location throughout the study.
* No severe psychiatric disorder or cognitive impairment; able to read, write, and understand the study information; willing to participate and provide written informed consent.
Exclusion Criteria:
* Olfactory impairment or known allergy to any ingredient in the herbal or placebo sachets.
* Use of sedative-hypnotic medication, antipsychotic medication, Chinese herbal medicine, or proprietary Chinese medicine affecting sleep during the previous 2 weeks.
* Major medical or psychiatric illness, including severe cardiovascular or cerebrovascular disease, severe respiratory depression, or impaired liver or kidney function.
Source: ClinicalTrials.gov (NCT07788547). StuddyBuddy aggregates publicly available trial information.