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

NCT03522207 | Terminated Phase 4

• 1 other identifier: 17.322
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

TMD; Sleep Bruxism; TMJ Pain; Chronic Pain; Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• Sleep stability score

  Based on visual analysis of these parameters: Sleep stage shifts: change from deeper to lighter sleep stage (stage 2, 3\&4, REM toward stages 1 or 2); measured as number/hour. Awakening: presence of alpha and beta electroencephalography (EEG) activities, with rise in submental/chin muscle tone, lasting\>10s; measured as number/hour. Movement arousal: an EEG pattern or awakening associated with major body movement; measured as number/hour. Microarousal (MA): abrupt shift in EEG frequency lasting more than 3s and less than 10, excluding spindles and K-complexes; measured as number/hour. Heart rate rapid fluctuations: acceleration of heart beat within 15s recorded by 2 electrodes at thoracic positions. Measured as number/hour. Presence and severity of abnormal values will be determined based on AASM recommended cutoffs. For value reference in TMD women participants, see Dubrovksy et al 2014. We hypothesize all these parameters would decrease in Trazodone group.

  8 hours after medication intake

Secondary Outcomes (1)

• Sleep quality score

  8 hours after medication intake

Other Outcomes (2)

• Subjective sleep quality

  8 hours after medication intake

• Clinical pain intensity

  8 hours after medication intake

Study Arms (2)

Trazo1

EXPERIMENTAL

After a baseline polysomnography (PSG), subject will receive 100 mg of trazodone 30 minutes prior to their 2nd PSG and will receive 100mg Placebo 30 minutes prior to their 3rd PSG.

Diagnostic Test: polysomnography; Drug: Trazodone; Drug: placebos

Trazo2

EXPERIMENTAL

After a baseline polysomnography (PSG), subject will receive 100 mg of placebo 30 minutes prior to their 2nd PSG and will receive 100mg trazodone 30 minutes prior to their 3rd PSG.

Diagnostic Test: polysomnography; Drug: Placebos; Drug: Trazodone

Interventions

polysomnography DIAGNOSTIC_TEST

BASELINE PSG Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.

Trazo1; Trazo2

Trazodone DRUG

100 mg trazodone or placebo given once 30 minutes prior to 2nd PSG

Trazo1

placebos DRUG

placebo per os 30 minutes prior to 2nd PSG

Trazo2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

CHUM

Montreal, Quebec, H3X 3E4, Canada

Location

MeSH Terms

Conditions

Sleep Bruxism; Chronic Pain; Sleep Wake Disorders

Interventions

Polysomnography; Trazodone

Condition Hierarchy (Ancestors)

Bruxism; Tooth Diseases; Stomatognathic Diseases; Parasomnias; Nervous System Diseases; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Gilles Lavigne

  Université de Montréal

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 11, 2018
• Study Start: October 15, 2018
• Primary Completion: January 20, 2020
• Study Completion: January 20, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CA (1)