Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06475378
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-11-15
Brief Title:
Enhancing Sleep Onset the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
Sponsor:
Vrije Universiteit Brussel
Organization:
Vrije Universiteit Brussel
Study Overview
Official Title:
Enhancing Sleep Onset the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOONBIRD
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 ie 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 andor waking up earlier than intended Additionally at least one daytime symptom needs to be present eg fatigue malaise low performance diminished concentration etc1-4 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None