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Can Cognitive Behavioral Therapy (CBT)-Insomnia be enhanced with clinical-grade, at-home sleep monitoring?: A Pilot study

The feasibility, acceptability, and effectiveness of enhancing CBT for insomnia with a digital platform incorporating home-based EEG and electronic sleep diary: A pilot study in adult participants aged 18-65

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000637549
Acronym
nil
Enrollment
6
Registered
2024-05-16
Start date
2024-05-30
Completion date
2024-12-02
Last updated
2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is exploring the possible benefits of adding clinical grade digital sleep assessment and clinician advice to the standard first line treatment for insomnia (Cognitive Behavioural Therapy-Insomnia, CBT-I). Specifically, we are evaluating the Somfit (https://www.compumedics.com.au/somfit) sleep monitoring device and Somfit program when added to standard Cognitive Behavioral Therapy for Insomnia (CBT-I). We will assess the feasibility, acceptability, and treatment outcomes compared to standalone CBT-I.

Interventions

Intervention: 4-8, weekly or fortnightly, 60 minute sessions of individually administered CBT-Insomnia (mostly in person, but telehealth sessions will be provided if required) that will be augmented with the use of a clinical grade, at-home sleep monitoring device (Somfit - see below). Participants can attend sessions weekly or fortnightly depending on convenience and clinical need as discussed with the treating clinician. Sessions will be held at two clinic urban locations in Perth, Western Au

Intervention: 4-8, weekly or fortnightly, 60 minute sessions of individually administered CBT-Insomnia (mostly in person, but telehealth sessions will be provided if required) that will be augmented with the use of a clinical grade, at-home sleep monitoring device (Somfit - see below). Participants can attend sessions weekly or fortnightly depending on convenience and clinical need as discussed with the treating clinician. Sessions will be held at two clinic urban locations in Perth, Western Australia: one university psychology training clinic, and one private behavioural sleep medicine clinic. Number of sessions will be determined by clinician's discretion of when appropriate CBT-Insomnia material has been delivered. -Therapy will be administered by clinical psychologists and supervised clinical psychology trainees. - number of sessions attended and dates of attendance will be recorded. - within the Somfit-CBT-I software, clinicians can indicate key CBT-Insomnia strategies that they have covered in each session. -Participation at the university trial site involves no cost to participants. Usual fees apply for participation at the private clinic. -Participants will be asked to complete questionnaire assessment measures at baseline, post-treatment and 3-month follow-up. These will take approximately 30minutes and include sleep log, Insomnia Severity Index, Depression Anxiety Stress Scales, and the Fatigue Assessment Scale. -Participants will be asked to wear the Somfit device for 5-7 nights at the above timepoints in order to gain an objective measurement of their sleep. -clinicians and participants will decide together how frequently to wear the Somfit device during the CBT-Insomnia treatment. CBT-Insomnia: Description of sessions: Clinicians can use their discretion in spending more or less time on particular therapy components, or changes in the ordering of content. Session 1-2 Therapist checks in on the participant’s experience of 7 nights Somfit recording At each therapist’s discretion and timing, they can share with each participant their sleep recording data. Assessment of insomnia history and maintaining factors via semi-structured clinical interview Participant goal setting and motivation for treatment Sleep education: myths and facts Regulation of Sleep – Sleep drive; Body clock; Are you an owl or lark? What is Insomnia? Strategies for improving sleep by changing behaviour – Wind down before bed; Stimulus control; Winding up Plan for the week ahead, including completing the sleep diary daily Therapist to decide whether more sleep studies to be done Session 2-4: Imagery exercise Review plan from last week and sleep diary Time in bed restriction Strategies for managing a busy mind vicious cycle of insomnia; Managing negative thoughts; Review and plan for the week ahead, including completing the sleep diary daily Therapist to decide whether more sleep studies need to be done Session 3-5: Beliefs About Sleep Scale (complete in session) Mindfulness exercise Weekly review of plan and sleep diary Introduction to defusion exercises Beliefs about sleep Daytime tiredness Insomnia cycle for the day Link between tiredness and sleep Maximising daytime energy Review and plan for the week ahead, including completing the sleep diary daily Therapist to decide whether more sleep studies need to be done Session 4-6: Weekly review and sleep diary Life balance and values Keeping your progress going: Blueprint for my sleep; Bad night sleep vs a relapse Planning for setbacks Review and plan for the future Encourage continuation of sleep diary if required in follow-up period Up to 2 additional therapy sessions can be added to consolidate the above content if the participant and therapist agree that this would be helpful for clinical outcomes. SOMFIT The Somfit device is not associated with any risk or harm. Somfit is a wearable, low voltage, battery operated device about the size of a 50c piece. Somfit collects signals such as EEG, heart rate, blood oxygen level, movement, body position, light, and noise. The Somfit device is attached to the participant's forehead through a self-adhesive and disposable skin electrode patch. Wearing the device may take a little getting used to, but most people adjust fairly quickly.

Sponsors

Compumedics Limited
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Prospective participants will need to be aged 18-65, be available to attend four to eight, weekly (or fortnightly) therapy sessions, and have an Insomnia Severity Index (ISI) score of 10 or above.

Exclusion criteria

The exclusion criteria are: (i) any co-morbid pre-diagnosed, non-treated sleep disorder (e.g., obstructive sleep apnoea, sleep-wake cycle disorders); (ii) the regular (3+nights per week) use of sleep related medication; (iii) any CBT-based treatment for insomnia in the previous 12-month period; (iv) women who are pregnant, breastfeeding or parents with infants who need to need caregive overnight; (v) any condition that is likely to impair the ability to participate in the treatment/study (e.g., severe mood difficulties; psychoses; neurological conditions; medical conditions requiring nursing care at night; alcohol/substance dependence; previous reaction to skin preparation, tapes and electrode gels used during PSG) ;

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026