Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
NCT Number: NCT06475378
Acronym: MOONBIRD
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Primary Insomnia
Interventions: DEVICE: Moonbird|BEHAVIORAL: Cognitive Behavioral Therapy for Insomnia
Sponsor: Vrije Universiteit Brussel
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-06-01

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.

Primary Outcome Measures: Sleep onset latency, Sleep onset latency (SOL) will be calculated with a sleep diary during the intervention or by polysomnography (PSG) during baseline and follow up., 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 Outcome Measures: The severity of insomnia, Insomnia Severity Index (ISI), is a 7-item questionnaire with scores: 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe), Baseline, Follow up (week 7 / 3 months after experiment)|Level of sleepiness, Epworth Sleepiness scale (ESS) is a 8-item questionnaire with scores of: 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness, Baseline, Follow up (week 7 / 3 months after experiment)|Current beliefs around sleep, Dysfunctional Beliefs and Attitudes around Sleep (DBAS), is a 24-item questionnaire. All responses should be added up and divide by 16. Those with scores 4 or greater, or those with high rating on an individual item (i.e., 6 or greater) may have unrealistic expectations for sleep or their thoughts about their sleep or their ability to cope with sleep loss have become a factor in their sleep problem., Baseline, Follow up (week 7 / 3 months after experiment)|Severity of anxiety and depression symptoms, Hospital Anxiety and Depression Scale (HADS), is a 14-item questionnaire. The higher the score on each subscale, the more symptoms:13 0-7 : no anxiety disorder or depression 8-10 : possible anxiety disorder or depression 11-21 : suspected anxiety disorder or depression, Baseline, Follow up (week 7 / 3 months after experiment)|Level of sleep quality, Pittsburgh Sleep Quality Index (PSQI), is a 19-item questionnaire where seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality., Baseline, Follow up (week 7 / 3 months after experiment)|Level of fatigue, Brugmann Fatigue Scale (BFS), is a 8-item questionnaire. Scores above 6 are suggested as cutoff values for both mental and physical subscales, each subscale has a min. of 0 and a max. of 12., Baseline, Follow up (week 7 / 3 months after experiment)|Overall health, Short Form Health Questionnaire (SF-36), is a 36-item questionnaire where higher score indicates better health status. For physical functioning, the minimum is 10 and the maximum is 30. For social functioning, the minimum is 2 and the maximum is 10. For role functioning related to physical problems, the minimum is 4 and the maximum is 8. For role functioning related to emotional problems, the minimum is 3 and the maximum is 6. For mental health, the minimum is 5 and the maximum is 30. For vitality, the minimum is 4 and the maximum is 24. For pain, the minimum is 11 and the maximum is 60. For general health perception, the minimum is 5 and the maximum is 25. For health change perception, the minimum is 1 and the maximum is 5., Baseline, Follow up (week 7 / 3 months after experiment)|Level of arousal before bedtime, Presleep Arousal Scale (PSAS) is a 16-item questionnaire that assesses the symptoms of cognitive and somatic arousal experienced at bedtime \[14\]. Items are rated on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely). The sum of scores of the first 8 items measures somatic pre-sleep arousal (PSAS-somatic), and the last 8 item scores-cognitive pre-sleep arousal (PSAS-cognitive). The clinically relevant cut-off scores reported for PSAS-somatic and PSAS-cognitive are ≥14 and ≥20, respectively, Baseline, Follow up (week 7 / 3 months after experiment)