Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

• Status: Terminated
• Trial end date: 2020-01-20
• Target enrollment: 0
• Participant gender: Female

Summary

The objective is to evaluate the accuracy and efficacity of 1 dose of trazodone in TMD patient (with chronic orofacial pain and poor sleep quality).

Subject will have 3 polysomnography (PSG) over 3 weeks. The first one being the baseline.

Half of the patient will receive trazodone on their 2nd PSG and placebo on their 3rd PSG, and the other half will receive placebo bedofe their 2nd PSG and trazodone for the 3rd PSG.

Pain quality and sleep quality will be assessed before and after PSG. polysomnograms from baseline, placebo night and trazodone night will also be compared.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Treatments: Trazodone

Criteria

Inclusion Criteria:

• painful TMD, defined as chronic myalgia (>6 months) with/without accompanying arthralgia per DC/TMD.

• Pain should have been present 15 days in the last month

• Pain of moderate to severe average intensity (at least 4 out 10 in a verbal numerical rating scale) in the last week.

• Poor sleep quality according to specific question of PSQI questionnaire (response of fairly bad or very bad sleep quality in the las month).

Exclusion Criteria:

• Presence of any dental or orofacial pain disorder not meeting the above definition.

• Use of other pharmacological treatment for TMD or sleep during duration of the study. Patients will be asked to discontinue any of those treatments before starting the study.

• Use of any psychotropic medication or drug known to influence sleep or pain such as amphetamines, benzodiazepines, anticonvulsants, neuroleptics, or antidepressants.

• Alcohol or substance abuse.

• Presence of major neurological or psychiatric disorders, such as epilepsy, schizophrenia or major depression; other sleep disorders such as narcolepsy, sleep apnea syndrome (SAS) or REM sleep behavior disorder.

• Presence of cardiovascular or bleeding disorders.

• History of tachycardia.

• Contraindications to Trazodone: previous allergic reaction to Trazodone, patients taking MAOIs.

• Pregnancy or lactation.