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

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ClinicalTrials.gov Identifier: NCT03522207
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Centre hospitalier de l'Université de Montréal (CHUM)

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.


Condition or disease Intervention/treatment Phase
TMD Sleep Bruxism TMJ Pain Chronic Pain Sleep Disorder Diagnostic Test: polysomnography Drug: Trazodone Drug: Placebos Drug: placebos Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Stabilisation de la qualité du Sommeil Chez le Sujet en Douleurs Orofaciales Chroniques - étude expérimentale en chassé croisé : Trazodone/ Placebo
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Trazo1
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
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.

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

Diagnostic Test: polysomnography
2nd psg, done 1 week after baseline. 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.

Drug: placebos
100 mg placebo per os 30 minutes prior to 3rd PSG

Diagnostic Test: polysomnography
3rd PSG, done 2 weeks after baseline. 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.

Experimental: Trazo2
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
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.

Drug: Placebos
placebo per os 30 minutes prior to 2nd PSG

Diagnostic Test: polysomnography
2nd psg, done 1 week after baseline. 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.

Drug: Trazodone
100 mg trazodone per os 30 minutes prior to 3rd PSG

Diagnostic Test: polysomnography
3rd PSG, done 2 weeks after baseline. 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.




Primary Outcome Measures :
  1. Sleep stability score [ Time Frame: 8 hours after medication intake ]

    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.



Secondary Outcome Measures :
  1. Sleep quality score [ Time Frame: 8 hours after medication intake ]

    Based on visual analysis of these parameters:

    Sleep duration: from time in bed to wake as estimated by EEG (minutes) Sleep efficiency: % time asleep/time in bed (time in minutes) Sleep fragmentation: index of all above criteria (point 1) number/hour Sleep latency: from light off to first sign of sleep on EEG (minutes). REM sleep latency: from sleep onset (on EEG) to first REM sleep stage (minutes).

    Presence and severity of abnormal values will be determined based on AASM recommended cutoffs. For references of values in TMD women participants, see Dubrovksy et al 2014. We hypothesize that sleep duration and efficiency will improve in Trazodone group, while sleep fragmentation, sleep latency, and REM sleep latency will decrease.



Other Outcome Measures:
  1. Subjective sleep quality [ Time Frame: 8 hours after medication intake ]
    Measured with a numerical rating scale (0 to 10) were 0 is poorest possible sleep quality and 10 is the greatest possible sleep quality

  2. Clinical pain intensity [ Time Frame: 8 hours after medication intake ]
    Measured with a numerical rating scale (0 to 100) were 0 is no pain and 100 is the most intense pain imaginable.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522207


Contacts
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Contact: cindy Prie (514) 890-8000 ext 14730 cindy.prie.chum@ssss.gouv.qc.ca
Contact: gilles lavigne 514-338-2222 ext 7564 gilles.lavigne@umontreal.ca

Locations
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Canada, Quebec
CHUM Recruiting
Montréal, Quebec, Canada, H3X 3E4
Contact: cindy prie    514-890-8000 ext 14730      
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Investigators
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Study Director: Gilles Lavigne Université de Montréal

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Responsible Party: Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT03522207     History of Changes
Other Study ID Numbers: 17.322
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Bruxism
Sleep Bruxism
Sleep Wake Disorders
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Parasomnias
Tooth Diseases
Stomatognathic Diseases
Trazodone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents