Primary InsomniaMOONBIRDNCT06475378
Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
A study testing Moonbird and Cognitive Behavioral Therapy for Insomnia in people with Primary Insomnia, run by Vrije Universiteit Brussel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Primary Insomnia
- What is being tested?
- Moonbird and Cognitive Behavioral Therapy for Insomnia
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must be diagnosed with chronic insomnia.
Who cannot join
- Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Moonbird, Cognitive Behavioral Therapy for Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoonbirdDevice
Moondbird is a technology-supported breathing exercise with a tactile breath pacer device
Cognitive Behavioral Therapy for InsomniaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Cognitive Behavioral Therapy for Insomnia (CBT-I) will be provided and seen as 'no intervention' Receives: 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) Receives: 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) Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, Follow up (week 7 / 3 months after experiment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start1 Mar 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary InsomniaStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier Mairesse, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475378
- Sponsor's protocol ID
- 23322_Moonbird
- Acronym
- MOONBIRD
- Status last verified
- Jun 2024
- First submitted
- 15 Nov 2023
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Sleep Onset: the Power of Tactile Breath Pacer in Cognitive Behavioral Therapy for Insomnia
- ClinicalTrials.gov ID
- NCT06475378
- Acronym / sponsor ID
- MOONBIRD / 23322_Moonbird
- Conditions
- Primary Insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 26 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia (CBT-I) will be provided and seen as 'no intervention' |
| CBT-I + Moonbird (MB) | Experimental | Device: Moonbird, Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia (CBT-I) will be combined with a technology supported breathing exercises with a tactile breath pacer device (Moonbird) |
| CBT-I + MBsham | Sham comparator | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia (CBT-I) will be combined with a non-functioning technology supported breathing exercises with a tactile breath pacer device (Moonbird) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients must be diagnosed with chronic insomnia.
Key exclusion criteria (1 listed)
- Underaged patients and patients with untreated comorbid (sleep) disorders will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoonbirdMoondbird is a technology-supported breathing exercise with a tactile breath pacer device | Device | CBT-I + Moonbird (MB) |
| Cognitive Behavioral Therapy for InsomniaCognitive 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. | Behavioural | CBT-I, CBT-I + MBsham, CBT-I + Moonbird (MB) |
Primary outcome
Sleep onset latency
Time frame: 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)
Sleep onset latency (SOL) will be calculated with a sleep diary during the intervention or by polysomnography (PSG) during baseline and follow up.
8 secondary outcomes
The severity of insomnia
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Level of sleepiness
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Current beliefs around sleep
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Severity of anxiety and depression symptoms
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Level of sleep quality
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Level of fatigue
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Overall health
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Level of arousal before bedtime
Time frame: Baseline, Follow up (week 7 / 3 months after experiment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Moonbird and Cognitive Behavioral Therapy for Insomnia in people with Primary Insomnia, run by Vrije Universiteit Brussel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zosia Goossens (02 629 25 26, zosia.goossens@vub.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset latency (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.