primary insomnia
Conditions
Interventions
Treatment group:Essential-Oil Inhalation Therapy
Control group:Routine bedtime health education
Sponsors
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18–80 years; sex unrestricted. (2) Primary complaint of insomnia meeting criteria 1)–7) for insomnia disorder in DSM-5. (3) Pittsburgh Sleep Quality Index (PSQI) global score > 7. (4) Corrected scores on both the Self-Rating Depression Scale and Self-Rating Anxiety Scale < 50. (5) If taking sleep-promoting medications, these must be limited to non-benzodiazepines, benzodiazepines, orexin-receptor antagonists, or melatonin-receptor agonists. (6) Willing to participate and has provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Failure to meet the above diagnostic or inclusion criteria. (2) Olfactory dysfunction or severe rhinitis. (3) Secondary insomnia, environmental sleep disorder, sleep-related breathing disorders (e.g., obstructive sleep apnea), or insomnia attributable to another psychiatric or medical condition. (4) Severe primary cardiac, hepatic, pulmonary, renal, or hematologic disease; any life-threatening illness; active psychiatric disorder; or significant suicide risk. (5) Current use of anxiolytic or antidepressant medications such as sertraline, deanxit, fluoxetine, escitalopram, paroxetine, or similar agents. (6) Alcohol or substance abuse/dependence within the past year. (7) Pregnant or lactating women. (8) Participation in another clinical drug trial within the 3 months prior to screening or currently enrolled in another trial. (9) Allergy history: hypersensitivity to plants in the Asteraceae (e.g., honeysuckle), Apiaceae (e.g., fennel), or Rutaceae (e.g., bergamot) families; or previous asthma attacks or severe rhinitis triggered by essential-oil inhalation. (10) Any other condition that, in the investigator's judgment, renders the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index ; | — |
Secondary
| Measure | Time frame |
|---|---|
| The 7-item factors of the Pittsburgh Sleep Quality Index (PSQI);Insomnia Severity Index ;Self-rating Depression Scale;Self-rating Anxiety Scale;Polysomnography parameters; | — |
Countries
China
Contacts
Public Contactqing ye
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Outcome results
None listed