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Insomnia ChronicRESTNCT06926348

Assessment of Usability and Preliminary Effectiveness of a Digital Sleep Aid in an Italian Sample

A study testing Digital Health Technology for Chronic Insomnia and Treatment as Usual (TAU) in people with Insomnia Chronic and Insomnia, run by Universita di Verona at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Chronic insomnia affects approximately 30% of the Italian population, leading to significant impairments in daily functioning and overall health. While Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, access is limited due to a shortage of trained specialists and resources… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Insomnia Chronic, Insomnia
What is being tested?
Digital Health Technology for Chronic Insomnia and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteItaly
Study dates
10 Mar 2025to 10 Mar 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 to 70 years
  • Diagnosis of chronic insomnia according to DSM-5 criteria
  • Willingness to participate in the study and provide informed consent
  • Personal active email address
  • Ownership of a compatible mobile device with internet access (for the DHT group)

Who cannot join

  • Medical conditions requiring hospital admission during the study period
  • Comorbid diagnosis of sleep-related breathing disorders
  • Neurological disorders affecting sleep (e.g., narcolepsy, parasomnias, epilepsy, neurodegenerative diseases)
  • Currently receiving psychological treatment for insomnia or planning to do so within the next 6 months
  • Incompatible smartphone or lack of internet access (for DHT group)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Elena Antelmi, Professor - Neurology contact

+393293526335

elena.antelmi@univr.it

Giacomo Carollo, MSc - Psychology contact

+393454361133

giacomo.carollo@univr.it

Italy1 site, 1 recruiting

  • Ospedale Borgo Roma - Neurologia B

    Verona, Verona, 37129

    Elena Antelmi, Professor - Neurology, 3293526335, elena.antelmi@univr.it

    Giacomo Carollo, MSc - Psychology, +393454361133, giacomo.carollo@univr.it

    Recruiting

Other trials in Italy

About this study

Official title: Usability, Acceptability, and Preliminary Effectiveness of a Digital Health Technology for Patient Monitoring of Chronic Insomnia Symptoms and the Promotion of Functional Sleep Behaviors: A Randomized Clinical Trial

Chronic insomnia affects approximately 30% of the Italian population, leading to significant impairments in daily functioning and overall health. While Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment, access is limited due to a shortage of trained specialists and resources within the Italian healthcare system. This study aims to evaluate the usability, acceptability, and preliminary effectiveness of a mobile application designed to assist individuals with chronic insomnia. The app offers digital sleep diaries, personalized sleep hygiene education, relaxation exercises, and an interactive chatbot to promote healthy sleep behaviors. Fifty adult participants diagnosed with chronic insomnia will be randomly assigned to either the intervention group, which will use the mobile application alongside their usual treatment, or to a control group receiving only standard care. The primary outcomes will assess the app's usability and participants' adherence to sleep hygiene practices. Secondary outcomes will evaluate changes in insomnia severity, mood, and quality of life. Assessments will occur at the start of the study, after the 8-week intervention, and at a 6-month follow-up to explore the intervention's long-term effects.

Read the detailed description

This randomized controlled pilot trial evaluates a Digital Health Technology (DHT) developed as a Health \& Wellness tool aimed at supporting individuals diagnosed with chronic insomnia. Chronic insomnia significantly impacts quality of life and poses a considerable burden on healthcare systems. Despite Cognitive Behavioral Therapy for Insomnia (CBT-I) being the recommended first-line treatment, its limited accessibility in Italy necessitates scalable and innovative solutions. The DHT under investigation is a mobile application developed collaboratively by the University of Verona and private-sector partners, designed specifically for educational purposes and the promotion of healthy sleep behaviors.

The intervention is structured over an 8-week period, during which participants are expected to engage daily with the application. The DHT includes several core functionalities:

Digital Sleep Diaries: Participants document their sleep habits daily, including sleep onset latency, total sleep duration, wake after sleep onset, and sleep efficiency. This self-monitoring aims to increase sleep-awareness and encourage consistent engagement with healthy sleep behaviors.

Personalized Educational Content: Users gain access to educational modules designed according to CBT-I principles. Topics include optimizing the sleep environment, maintaining consistent sleep schedules, managing lifestyle factors affecting sleep, and addressing common misconceptions about sleep.

Relaxation and Mindfulness Exercises: The app provides guided audio and video exercises focusing on relaxation techniques such as deep breathing and progressive muscle relaxation, alongside mindfulness practices intended to reduce pre-sleep arousal and facilitate better sleep.

Interactive Chatbot: An integrated conversational agent assists users in navigating app functionalities, provides personalized reminders, motivational feedback, and real-time assistance, enhancing user engagement and compliance.

Participants (N=50) are recruited from the outpatient clinic at Borgo Roma Hospital, Verona. Eligible individuals are randomly assigned in a 1:1 ratio to either receive the DHT intervention combined with Treatment as Usual (DHT + TAU), or Treatment as Usual (TAU) alone. TAU involves standardized educational materials on sleep hygiene practices provided via printed booklets and continued management under the patient's usual healthcare provider.

Assessments are conducted at baseline (T0), immediately post-intervention (T1), and at a 6-month follow-up (T2). Primary outcomes focus on usability and acceptability, measured by the User Experience Questionnaire (UEQ), digital engagement metrics, and adherence to sleep hygiene practices via the Sleep Hygiene Index (SHI). Secondary outcomes assess preliminary efficacy regarding insomnia severity (Insomnia Severity Index - ISI), mood disturbances (Hospital Anxiety and Depression Scale - HADS), and overall health-related quality of life (Short Form Health Survey - SF-12).

Data collection employs the secure LimeSurvey platform to ensure participant confidentiality and data protection according to GDPR standards. Data analysis includes Linear Mixed Effects Models, exploratory analyses for identifying predictors of treatment response, and sensitivity analyses for assessing robustness of findings.

This feasibility trial aims to inform future large-scale studies by evaluating the potential benefits and limitations of using a scalable, non-medical DHT in the routine management of chronic insomnia. Results are anticipated to contribute substantially to the evidence base supporting digital interventions as viable adjuncts to standard care for insomnia.

Being tested
Digital Health Technology for Chronic Insomnia, Treatment as Usual (TAU)
Keywords
Insomnia, CBT-i, Cognitive Behavioral Therapy for Insomnia, Digital Health Technology, DTx
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.

  • Digital Health Technology for Chronic InsomniaBehavioural

    A mobile application designed to support chronic insomnia management through digital self-monitoring of sleep patterns, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and chatbot interactions. Users receive tailored notifications and educational content to encourage healthy sleep behaviors over an 8-week period. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged

  • Treatment as Usual (TAU)Behavioural

    Participants receive standard sleep hygiene recommendations via a printed educational booklet. They maintain printed sleep diaries for daily self-monitoring throughout the 8-week intervention. Existing pharmacological treatments prescribed prior to study enrollment continue unchanged.

Study groups in NCT06926348
Study groupRoleWhat they receive
Digital Health Technology (DHT) + Treatment As Usual (TAU)ExperimentalParticipants in this arm receive an 8-week intervention involving a mobile app designed for chronic insomnia management. The app includes digital sleep diaries, personalized sleep hygiene education, cognitive strategies, relaxation and mindfulness exercises, and an interactive chatbot for enhanced engagement. This intervention complements standard treatment (TAU), which may include pharmacotherapy and routine clinical care.
Receives: Behavioral: Digital Health Technology for Chronic Insomnia
Treatment As Usual (TAU)Active comparatorParticipants assigned to this arm continue their usual insomnia management, including pharmacological treatments if prescribed, and receive standardized educational material on sleep hygiene practices via a printed booklet. They also maintain printed sleep diaries for self-monitoring throughout the 8-week study period.
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Usability and Acceptability of Digital Health Technology (DHT)

    Usability and acceptability measured by the User Experience Questionnaire (UEQ) and digital engagement metrics, including app access frequency, session duration, notification interactions, and drop-out rates.

    Measured: After 8 weeks of intervention (T1)

  2. Adherence to Sleep Hygiene Practices

    Change in adherence to recommended sleep hygiene behaviors assessed through the Sleep Hygiene Index (SHI).

    Measured: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

Secondary outcomes (3)

  1. Insomnia Severity Index (ISI)

    Change in insomnia severity measured using the Insomnia Severity Index, evaluating subjective sleep disturbance and related daytime impairment.

    Measured: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

  2. Mood and Emotional Distress

    Change in anxiety and depression symptoms assessed using the Hospital Anxiety and Depression Scale (HADS).

    Measured: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

  3. Health-Related Quality of Life

    Change in quality of life across multiple dimensions (e.g., physical functioning, emotional wellbeing) assessed using the Short Form Health Survey (SF-12).

    Measured: Baseline (T0), after 8 weeks (T1), and at 6-month follow-up (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2025
  2. Study start10 Mar 2025
  3. Primary completion1 Oct 2025 (estimated)
  4. Study completion10 Mar 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06926348
Sponsor's protocol ID
413CET
Acronym
REST
Status last verified
Apr 2025
First submitted
6 Apr 2025
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The individual participant data (IPD) collected in this study will not be shared due to institutional data protection policies and GDPR compliance. Given the sensitivity of health-related personal data and the nature of the digital tools involved, sharing IPD externally poses potential privacy and security risks that cannot be sufficiently mitigated. Additionally, participants were informed that their data would only be accessible to authorized personnel directly involved in the research.

Publications

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Watanabe Y, Kuroki T, Ichikawa D, Ozone M, Uchimura N, Ueno T. Effect of smartphone-based cognitive behavioral therapy app on insomnia: a randomized, double-blind study. Sleep. 2023 Mar 9;46(3):zsac270. doi: 10.1093/sleep/zsac270.

    PubMed 36355920

  • Terzano MG, Parrino L, Cirignotta F, Ferini-Strambi L, Gigli G, Rudelli G, Sommacal S; Studio Morfeo Committee. Studio Morfeo: insomnia in primary care, a survey conducted on the Italian population. Sleep Med. 2004 Jan;5(1):67-75. doi: 10.1016/j.sleep.2003.09.006.

    PubMed 14725829

  • Stepanski EJ, Wyatt JK. Use of sleep hygiene in the treatment of insomnia. Sleep Med Rev. 2003 Jun;7(3):215-25. doi: 10.1053/smrv.2001.0246.

    PubMed 12927121

  • Spielman AJ, Caruso LS, Glovinsky PB. A behavioral perspective on insomnia treatment. Psychiatr Clin North Am. 1987 Dec;10(4):541-53.

    PubMed 3332317

  • Shapiro SL, Carlson LE, Astin JA, Freedman B. Mechanisms of mindfulness. J Clin Psychol. 2006 Mar;62(3):373-86. doi: 10.1002/jclp.20237.

    PubMed 16385481

  • Shamim SA, Warriach ZI, Tariq MA, Rana KF, Malik BH. Insomnia: Risk Factor for Neurodegenerative Diseases. Cureus. 2019 Oct 26;11(10):e6004. doi: 10.7759/cureus.6004.

    PubMed 31807391

  • Schuffelen J, Maurer LF, Lorenz N, Rotger A, Pietrowsky R, Gieselmann A. The clinical effects of digital cognitive behavioral therapy for insomnia in a heterogenous study sample: results from a randomized controlled trial. Sleep. 2023 Nov 8;46(11):zsad184. doi: 10.1093/sleep/zsad184.

    PubMed 37428712

  • Riemann D, Espie CA, Altena E, Arnardottir ES, Baglioni C, Bassetti CLA, Bastien C, Berzina N, Bjorvatn B, Dikeos D, Dolenc Groselj L, Ellis JG, Garcia-Borreguero D, Geoffroy PA, Gjerstad M, Goncalves M, Hertenstein E, Hoedlmoser K, Hion T, Holzinger B, Janku K, Jansson-Frojmark M, Jarnefelt H, Jernelov S, Jennum PJ, Khachatryan S, Krone L, Kyle SD, Lancee J, Leger D, Lupusor A, Marques DR, Nissen C, Palagini L, Paunio T, Perogamvros L, Pevernagie D, Schabus M, Shochat T, Szentkiralyi A, Van Someren E, van Straten A, Wichniak A, Verbraecken J, Spiegelhalder K. The European Insomnia Guideline: An update on the diagnosis and treatment of insomnia 2023. J Sleep Res. 2023 Dec;32(6):e14035. doi: 10.1111/jsr.14035.

    PubMed 38016484

  • Riemann D, Spiegelhalder K, Feige B, Voderholzer U, Berger M, Perlis M, Nissen C. The hyperarousal model of insomnia: a review of the concept and its evidence. Sleep Med Rev. 2010 Feb;14(1):19-31. doi: 10.1016/j.smrv.2009.04.002. Epub 2009 May 28.

    PubMed 19481481

  • Riemann D, Nissen C, Palagini L, Otte A, Perlis ML, Spiegelhalder K. The neurobiology, investigation, and treatment of chronic insomnia. Lancet Neurol. 2015 May;14(5):547-58. doi: 10.1016/S1474-4422(15)00021-6. Epub 2015 Apr 12.

    PubMed 25895933

  • Riemann D, Baglioni C, Bassetti C, Bjorvatn B, Dolenc Groselj L, Ellis JG, Espie CA, Garcia-Borreguero D, Gjerstad M, Goncalves M, Hertenstein E, Jansson-Frojmark M, Jennum PJ, Leger D, Nissen C, Parrino L, Paunio T, Pevernagie D, Verbraecken J, Weess HG, Wichniak A, Zavalko I, Arnardottir ES, Deleanu OC, Strazisar B, Zoetmulder M, Spiegelhalder K. European guideline for the diagnosis and treatment of insomnia. J Sleep Res. 2017 Dec;26(6):675-700. doi: 10.1111/jsr.12594. Epub 2017 Sep 5.

    PubMed 28875581

  • Palagini L, Piarulli A, Menicucci D, Cheli E, Lai E, Bergamasco M, Mauri M, Kyle SD, Espie CA, Gemignani A. Metacognitive beliefs relate specifically to sleep quality in primary insomnia: a pilot study. Sleep Med. 2014 Aug;15(8):918-22. doi: 10.1016/j.sleep.2014.03.017. Epub 2014 May 9.

    PubMed 24916095

  • Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186.

    PubMed 12531146

  • Ning Y, Teixayavong S, Shang Y, Savulescu J, Nagaraj V, Miao D, Mertens M, Ting DSW, Ong JCL, Liu M, Cao J, Dunn M, Vaughan R, Ong MEH, Sung JJ, Topol EJ, Liu N. Generative artificial intelligence and ethical considerations in health care: a scoping review and ethics checklist. Lancet Digit Health. 2024 Nov;6(11):e848-e856. doi: 10.1016/S2589-7500(24)00143-2. Epub 2024 Sep 17.

    PubMed 39294061

Questions about this trial

What is this clinical trial studying?

A study testing Digital Health Technology for Chronic Insomnia and Treatment as Usual (TAU) in people with Insomnia Chronic and Insomnia, run by Universita di Verona at 1 site in Italy.

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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elena Antelmi, Professor - Neurology (+393293526335, elena.antelmi@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Usability and Acceptability of Digital Health Technology (DHT) (time frame: After 8 weeks of intervention (T1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06926348, which also lists 31 linked publications.

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 17 Apr 2025.

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