Chronic insomnia
Conditions
Interventions
Dexmedetomidine hydrochloridenasal spray group:dexmedetomidine hydrochloride 2/kg nasal spray
Normal saline nasal spray group:Equal dose saline nasal spray
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age:18-65 years old; 2.Meet the diagnostic criteria of chronic insomnia of ICSD-3:All participants underwent a diagnostic interview conducted by an experienced physician based on the ICSD-3 criteria for chronic insomnia: (1) Dissatisfaction with sleep quality; (2) One or more of the following sleep difficulties: difficulty falling asleep, difficulty maintaining sleep, or early morning awakening; (3) Significant distress or impairment in daily functioning due to sleep difficulties; (4) Sleep difficulties occurring at least three times per week; (5) Sleep difficulties persisting for at least three months; (6) Sleep difficulties occurring despite adequate opportunity and conditions for sleep. 3.Pittsburgh Sleep Quality Index (PSQI) score >=11.
Exclusion criteria
Exclusion criteria: 1.Patients with severe mental illness; 2.Unable to suspend the use of psychotropic drugs, central nervous system depressants or drugs to help sleep during the study; 3.Patients with heart block, severe cardiac insufficiency, severe liver insufficiency, renal insufficiency, severe respiratory insufficiency, or other serious physical disease; 4.Pregnant and lactating women; 5.Patients allergic to dexmedetomidine; 6.Patients with rhinitis attack; 7.Patients with metal implants in bodies;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep latency in the night after medication in both groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| The ISI scale scores of the two groups of patients on the 7th day after medication administration;The average duration of awakening after falling asleep for both groups of patients 7 days after medication administration;The HAMD scale scores of the two groups of patients on the 7th day after medication administration;The duration of N1 stage sleep for the two groups of patients on the night after medication administration;The total sleep time duration on the night after medication administration in both groups of patients.;The duration of awakening during sleep after treatment for the two groups of patients on the same night;The average number of awakenings after falling asleep in the two groups of patients 7 days after medication administration;The ESS scale scores of the two groups of patients on the 7th day after medication administration;The average sleep efficiency of the two groups of patients 7 days after medication administration;The proportion of patients in both groups who had N2 stage sleep for a certain duration after medication administration on the same night;The duration of N3 stage sleep for the two groups of patients on the night after medication administration;The average proportion of REM sleep in the two groups of patients 7 days after medication administration;The proportion of patients in both groups who had N3 stage sleep for a certain duration after medication administration on the same night;The HAMA scale scores of the two groups of patients on the 7th day after medication administration;The average proportion of light sleep duration for the two groups of patients 7 days after medication administration;The proportion of REM sleep duration at night after medication administration for the two groups of patients;The average proportion of deep sleep duration for the two groups of patients 7 days after medication administration;The sleep efficiency of the two groups of patients on the night after medication administration;The duration of N2 stag | — |
Countries
China
Contacts
Public ContactYan Luo
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed