Stabilisation de la qualité du Sommeil Chez le Sujet en Douleurs Orofaciales Chroniques - étude expérimentale en chassé croisé : Trazodone/ Placebo
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Sleep stability score
研究概览
简要总结
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.
详细描述
Temporomandibular disorders (TMD) is an umbrella term to describe different disorders that affect the temporomandibular joint (TMJ) and/or muscles of mastication 1. TMD is one of the most common chronic orofacial pain conditions and the second most commonly occurring musculoskeletal condition, affecting 5-12% of the U.S and Canada. As other chronic pain conditions, TMD significantly impacts patients' quality of life (sleep quality, mood, eating, energy, etc). It is frequently associated with psychological conditions such as anxiety, depression, or somatization, which are often related with central sensitization and disability. The importance of the psychological axis for diagnose and treat TMD along with other orofacial pain disorders is reflected in the ongoing process of including psychosocial variables in the new orofacial pain classification.
The NIH funded Orofacial Pain Prospective Evaluation and Risk Assessment (OPPERA) study is probably one of the most important and well-funded investigations assessing risk factors for new onset and chronicity of TMD. This comprehensive study found that other comorbidities, self-report of jaw parafunction, and somatization were important predictors for clinical TMD. It was also found that deteriorated subjective sleep quality, assessed using the Pittsburgh Sleep quality Index (PSQI), it is present in TMD patients, can also predict incidence of TMD.
Sleep quality can be assessed subjectively or objectively:
- Subjectively, it has been defined as tiredness on waking and throughout the day, feeling rested and restored on waking, and the number of awakenings they experienced in the night. It is usually assessed by self-report through questionnaires, such as the PSQI or visual analogue or category scales. Numerous studies, see above, reported poor subjective sleep quality in TMD subjects; a finding that has also been observed in different chronic pain conditions such as fibromyalgia or neuropathic pain.
- Objectively, sleep quality is assessed through polysomnographic evaluation (PSG), and it is defined as sufficient duration (> 7hrs), high efficiency (> 85%), and low fragmentation (< 25), as well as proper staging of sleep. Smith et al showed that sleep disturbances and sleep disorders are prevalent among TMD patients using PSG; and Dubrovsky et al. compared sleep architecture of 126 TMD cases with 46 matched controls, finding that in TMD patients there was an increase of N1 stage of sleep, an increase in arousals associated with respiratory events, and also in respiratory effort related arousals (RERAs).
Therefore, the results of these studies suggest that patients with TMD present decreased subjective and objective sleep quality when compared to controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: polysomnography (Diagnostic Test)
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.
干预措施: Trazodone (Drug)
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.
干预措施: placebos (Drug)
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.
干预措施: polysomnography (Diagnostic Test)
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.
干预措施: placebos (Drug)
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.
干预措施: Trazodone (Drug)
结局指标
主要结局
Sleep stability score
时间窗: 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.
次要结局
- Sleep quality score(8 hours after medication intake)