Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia

NCT ID: NCT06475378

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2026-09-01

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.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-I

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be provided and seen as 'no intervention'

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended, first-line treatment for chronic insomnia, as it is proven to be highly effective in improving sleep quality. It is a multifaceted approach, which includes time-in-bed restriction (i.e., reducing time spent in bed to enhance sleep consolidation), stimulus control (i.e., restricting behaviours incompatible with sleep in the bedroom), and cognitive restructuring (i.e., addressing and altering maladaptive thoughts and beliefs regarding sleep) to reinstate a regular sleep pattern.

CBT-I + Moonbird (MB)

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be combined with a technology supported breathing exercises with a tactile breath pacer device (Moonbird)

Group Type: EXPERIMENTAL

Moonbird

Intervention Type: DEVICE

Moondbird is a technology-supported breathing exercise with a tactile breath pacer device

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended, first-line treatment for chronic insomnia, as it is proven to be highly effective in improving sleep quality. It is a multifaceted approach, which includes time-in-bed restriction (i.e., reducing time spent in bed to enhance sleep consolidation), stimulus control (i.e., restricting behaviours incompatible with sleep in the bedroom), and cognitive restructuring (i.e., addressing and altering maladaptive thoughts and beliefs regarding sleep) to reinstate a regular sleep pattern.

CBT-I + MBsham

Cognitive Behavioral Therapy for Insomnia (CBT-I) will be combined with a non-functioning technology supported breathing exercises with a tactile breath pacer device (Moonbird)

Group Type: SHAM_COMPARATOR

Cognitive Behavioral Therapy for Insomnia

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended, first-line treatment for chronic insomnia, as it is proven to be highly effective in improving sleep quality. It is a multifaceted approach, which includes time-in-bed restriction (i.e., reducing time spent in bed to enhance sleep consolidation), stimulus control (i.e., restricting behaviours incompatible with sleep in the bedroom), and cognitive restructuring (i.e., addressing and altering maladaptive thoughts and beliefs regarding sleep) to reinstate a regular sleep pattern.

Interventions

Moonbird

Moondbird is a technology-supported breathing exercise with a tactile breath pacer device

Intervention Type: DEVICE

Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended, first-line treatment for chronic insomnia, as it is proven to be highly effective in improving sleep quality. It is a multifaceted approach, which includes time-in-bed restriction (i.e., reducing time spent in bed to enhance sleep consolidation), stimulus control (i.e., restricting behaviours incompatible with sleep in the bedroom), and cognitive restructuring (i.e., addressing and altering maladaptive thoughts and beliefs regarding sleep) to reinstate a regular sleep pattern.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Olivier Mairesse

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zosia Goossens

Role: CONTACT

zosia.goossens@vub.be

02 629 25 26

Other Identifiers

23322_Moonbird

Identifier Type: -

Identifier Source: org_study_id