Efficacy of Cranial Manual Therapy in the Treatment of Chronic Insomnia Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Insomnia Severity
研究概览
简要总结
Insomnia is the most prevalent sleep disorder in society. The first treatment of choice is pharmacology, although it can have secondary effects such as tolerance and dependence, or alter the structure of sleep; therefore, new pathways towards other adjuvant treatments are being established. OBJECTIVES: The main objective is "To assess the effectiveness of manual cranial therapy on the quantity and quality of sleep in patients with chronic insomnia." MATERIAL AND METHODS: A randomized clinical trial is designed, with two groups, intervention and placebo, to assess the effectiveness of manual therapy applied to the skull, in the severity of insomnia, and quantity and quality of sleep in patients with sleep disorder. chronic insomnia. Health professionals will be selected from the Department of Occupational Health, with characteristics of chronic insomnia described by the ICSD-III, who do not modify their usual medication regimen (if they take it) and without other pathologies related to sleep that may be causing the insomnia. insomnia Demographic data (age, sex, profession), clinical (BMI, history of previous and family insomnia pathologies, and taking medication for sleep and related disorders), sleep quality questionnaires (PSQI, COS, ISI) will be collected. , stress-insomnia relationship (FISRST-S), and quality of life (SF12), in addition to filling out a sleep diary (through the mobile App) and recording activity through actigraphy, hypnogram (Sleep ProfilerTM); before and after the intervention, and at one and three month follow-up. Each group will receive the offered intervention: cranial manual therapy (intervention) or cranial massage (placebo). The data will be coded and analyzed with the IBM SPSS® version 20 program (or similar)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic insomnia disorder according to the criteria defined by the ICSD-III (International Classification of Sleep Disorders-3rd edition):
- •Problems initiating or maintaining sleep, associated with daytime consequences; and not attributable to environmental circumstances.
- •Insomnia lasting more than 3 months, with episodes of at least 3 times a week.
- •Regarding the pharmacology or medication indicated for sleep:
- •They do not want to take the medication recommended by the doctor who is treating them.
- •Do not change their usual drug regimen, if they were already taking medication to sleep.
- •They are not taxed to take medication.
- •Having ruled out other pathologies related to sleep through:
- •Respiratory polygraphy to rule out sleep-related respiratory pathologies (SAHS).
- •screening to rule out motor sleep disorders.
- •screening to rule out circadian sleep disorders.
- •screening to rule out serious psychiatric disorders (depression, anxiety, general psychopathology): BDI-II (Beck Depression Inventory), BAI (Beck Anxiety Inventory), SCL-
- •Obtain a score greater than 7 points (clinical-subclinical insomnia).
排除标准
- •Obtain a score of less than 7 (clinically insignificant insomnia) in the ISI test (Insomnia Severity Index).
- •The result of the respiratory polygraphy is positive, confirming a sleep-disordered breathing.
- •The screening tests for the detection of motor sleep disorders, respiratory sleep disorders or circadian disorders are positive.
- •The Screening detects serious psychiatric illnesses such as major depressive disorder or bipolar disorders is positive.
- •Suffering or having suffered from any central neurological pathology, stroke, aneurysm...
- •Having suffered skull fractures.
- •Having undergone surgery in the last 6 months and that insomnia has started as a result of it.
结局指标
主要结局
Insomnia Severity
时间窗: 18 weeks
With an "Insomnia Severity Index" (ISI). There are seven items. Each item is rated on a scale from 0 to 4 from less to more severe. The total score is the sum of each individual item and can range from 0 to 28 (28 = most severe insomnia).
次要结局
- Vulnerability to stress-related insomnia(9 weeks)
- Quality of Life of patients with insomnia(18 weeks)
- Hypnogram-Polysomnography - Macro and microstructure of sleep(18 weeks)
- Heart Rate Variability(4 weeks)
- Quantity, latency and efficiency of sleep(18 weeks)
- Sleep Quality(18 weeks)
研究者
Maider Sánchez Padilla
Principal Investigator
Escoles Universitaries Gimbernat