Clinical trial NCT06475378: Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
Official title: Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Primary Insomnia
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2024-06-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial (RCT)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Patients must be diagnosed with chronic insomnia.

Exclusion Criteria:

* Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.

Primary outcomes:
measure: Sleep onset latency
timeFrame: 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)
Secondary outcomes:
measure: The severity of insomnia
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Level of sleepiness
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Current beliefs around sleep
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Severity of anxiety and depression symptoms
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Level of sleep quality
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Level of fatigue
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Overall health
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
measure: Level of arousal before bedtime
timeFrame: Baseline, Follow up (week 7 / 3 months after experiment)
Other outcomes:
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