Sleep bruxism
Conditions
Interventions
A group:Placebo intervention + Agomelatine intervention at least 24 hours after placebo intervention
B group:Agomelatine intervention + Placebo intervention at least 24 hours after agomelatine intervention
Sponsors
Jiangxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Inclusion criteria
Inclusion criteria: 1. Adult male or female aged 18-35 years; 2. Meet the following criteria for sleep bruxism: (1) Grinding teeth at least three times a week in the past six months; (2) Complaints of facial muscle pain, weakness or other orofacial discomfort when getting up in the morning; (3) Tooth wear; (4) Masseter muscle or temporalis muscle hypertrophy; 3. The results of polysomnography meet the diagnostic criteria for sleep bruxism of the American Academy of Sleep Medicine.
Exclusion criteria
Exclusion criteria: 1. Have any sleep disorders other than sleep bruxism, such as: obstructive sleep apnea syndrome, restless legs syndrome, insomnia, rapid eye movement sleep behavior disorder, etc.; 2. have a history of neurological disease or mental illness; 3. Taking drugs within one month before the full-night polysomnography or during the test; 4. smokers and alcoholics; 5. Drinking exciting beverages (coffee, tea, etc.) on the day of the experiment; 6. Patients who are contraindicated in the use of agomelatine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of oral movements;Number and frequency of different types of sleep bruxism and clusters of sleep bruxism;The frequency and occurrence of sleep grinding during each sleep period;The number and frequency of isolated limb movements, isolated sleep bruxism and sleep bruxism with limb movements during sleep period;Heart rate and heart rate variability associated with sleep bruxism; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total sleep time, sleep efficiency and sleep latency;The number and frequency of arousal;The proportion of each sleep period;Heart rate and heart rate variability in each sleep period;Sleep periodic limb movement index;Obstructive sleep apnea hypopnea index; | — |
Countries
China
Contacts
Public ContactDongyuan Yao
Jiangxi Provincial People's Hospital
Outcome results
None listed