Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Sleep onset latency
研究概览
简要总结
The purpose of the study is to evaluate the effectiveness of technology-assisted breathing exercises combined with Cognitive Behavioral Therapy for Insomnia (CBT-I) in primary insomnia patients to investigate. For this purpose, we will conduct 1 study. This will be a randomized controlled trial in which 72 patients randomly and stratified by gender will be divided into 3 groups. A first group follows the standard treatment Cognitive Behavioral Therapy for Insomnia (CBT-I), the second group follows the combined treatment Cognitive Behavioral Therapy for Insomnia with a technology supported breathing exercises with a tactile breath pacer device (Moonbird) (CBT-I + Moonbird) and a third group follows the standard treatment Cognitive Behavioral Therapy for Insomnia and receives a non-functional technology supported breathing exercises with a tactile breath pacer device (Moonbird). The therapy, baseline measurements, screening for inclusion and questionnaire administration and ambulatory polysomnography (PSG) will be performed by the sleep psychologists at the UZ Brussel. The polysomnography screening for in- or exclusion (i.e. presence of other untreated sleep disorders) will be performed at the UZ Brussel. Furthermore, two follow-up measurements will be scheduled. The first measurement will take place immediately after the treatment while the second measurement will take place 3 months after the treatment.
详细描述
Insomnia is defined as a subjective complaint in initiating, maintaining and/or waking up earlier than intended. Additionally, at least one daytime symptom needs to be present (e.g. fatigue, malaise, low performance, diminished concentration, etc.1-4 When this complaint occurs at least three nights a week and persists for at least three months, it is categorized as chronic insomnia4.
Cognitive behavioral therapy for insomnia (CBT-I) is the recommended, first-line treatment for chronic insomnia. It is proven to be highly effective to consolidate sleep. Cognitive Behavioral Therapy for Insomnia (CBT-I) comprises of multiple components such as psychoeducation, stimulus control, time in bed restriction, cognitive therapy, and relaxation training.
Relaxation techniques such as mindfulness learn to redirect the attention to the act of breathing without changing it. Therein lies the difference with breathing exercises, where a person consciously changes breathing depth, pace or inspiration-expiration ratio. Several studies show activation of the parasympatic nervous system (promoting the rest-and-digest response) with breathing exercises. Furthermore, preliminary findings demonstrate feasible usage of technology supported breathing exercises with a tactile breath pacer, potentially leading to an enhancement in sleep quality.
Therefore, the primary scientific objective of this study is to examine the added value of a technology supported breathing exercises with a tactile breath pacer (Moonbird) added to Cognitive behavioral therapy for insomnia (CBT-I), to further enhance sleep quality and improved sleep onset.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The researcher performing the statistics and outcome assessors will be blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must be diagnosed with chronic insomnia.
排除标准
- •Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.
结局指标
主要结局
Sleep onset latency
时间窗: Baseline (week 0; PSG), through completion of the intervention phase (weeks 1,2,3,4,5,6,7; sleep diary), First follow up (week 8; PSG), second follow up (3 months after the intervention; PSG)
Sleep onset latency (SOL) will be calculated with a sleep diary during the intervention or by polysomnography (PSG) during baseline and follow up.
次要结局
- Level of fatigue(Baseline, Follow up (week 7 / 3 months after experiment))
- The severity of insomnia(Baseline, Follow up (week 7 / 3 months after experiment))
- Level of sleepiness(Baseline, Follow up (week 7 / 3 months after experiment))
- Level of sleep quality(Baseline, Follow up (week 7 / 3 months after experiment))
- Current beliefs around sleep(Baseline, Follow up (week 7 / 3 months after experiment))
- Severity of anxiety and depression symptoms(Baseline, Follow up (week 7 / 3 months after experiment))
- Overall health(Baseline, Follow up (week 7 / 3 months after experiment))
- Level of arousal before bedtime(Baseline, Follow up (week 7 / 3 months after experiment))
研究者
Olivier Mairesse
Prof
Vrije Universiteit Brussel