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

NCT06475378 | Not Yet Recruiting DMC

• 1 other identifier: 23322_Moonbird
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Primary Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

• 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)

• Level of sleep quality

  Baseline, Follow up (week 7 / 3 months after experiment)

Study Arms (3)

CBT-I

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy for Insomnia

CBT-I + Moonbird (MB)

EXPERIMENTAL

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

Device: Moonbird; Behavioral: Cognitive Behavioral Therapy for Insomnia

CBT-I + MBsham

SHAM COMPARATOR

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)

Behavioral: Cognitive Behavioral Therapy for Insomnia

Interventions

Moonbird DEVICE

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

CBT-I + Moonbird (MB)

Cognitive Behavioral Therapy for Insomnia 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; CBT-I + MBsham; CBT-I + Moonbird (MB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be diagnosed with chronic insomnia.

You may not qualify if:

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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Zosia Goossens

CONTACT

02 629 25 26; zosia.goossens@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researcher performing the statistics and outcome assessors will be blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Randomized controlled trial (RCT)

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: June 26, 2024
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 18, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share