Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06926348

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

Led by Universita di Verona · Updated on 2025-04-17

50

Participants Needed

1

Research Sites

22 weeks

Total Duration

On this page

Sponsors

U

Universita di Verona

Lead Sponsor

S

Santer Reply S.p.A. Milan, Italy

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic insomnia affects about 30% of the Italian population and can significantly impair daily life and health. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the preferred treatment, but limited access to trained specialists in Italy has created a need for new solutions. This trial evaluates a mobile app designed to support people with chronic insomnia by promoting healthy sleep habits and monitoring sleep patterns. The study is a randomized controlled pilot trial involving 50 adults diagnosed with chronic insomnia. Participants are randomly assigned to one of two groups: the intervention group uses the mobile app alongside their usual treatment, and the control group receives standard care alone. The mobile app includes daily digital sleep diaries, personalized sleep hygiene education based on CBT-I, relaxation and mindfulness exercises, and an interactive chatbot to encourage engagement. The intervention lasts 8 weeks, with the control group receiving printed educational booklets and self-monitoring diaries. Participants will be assessed at the start of the study, immediately after the 8-week intervention, and again at a 6-month follow-up. Researchers will measure the app's usability, participants' adherence to sleep hygiene practices, and changes in insomnia severity, mood, and quality of life. Data collection is conducted securely online to protect privacy. This study aims to determine if this digital health tool could be a helpful addition to standard insomnia care and guide larger future studies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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)
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 8 weeks

Participants engage in an 8-week behavioral intervention for chronic insomnia. Those in the experimental group use a mobile application daily that includes digital sleep diaries, personalized sleep hygiene education, relaxation and mindfulness exercises, and an interactive chatbot. Participants in the comparator group receive standard care with printed educational materials and maintain printed sleep diaries. Existing pharmacological treatments continue unchanged.

Daily self-monitoring with either app or printed diaries during the 8 weeks

Follow-up

Duration - 6 months

Participants complete assessments to evaluate adherence to sleep hygiene practices, insomnia severity, mood, and quality of life at 6 months after the intervention ends.

1 follow-up assessment

Trial Site Locations

Total: 1 location

1

Ospedale Borgo Roma - Neurologia B

Verona, Verona, Italy, 37129

Actively Recruiting

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Research Team

E

Elena Antelmi, Professor - Neurology

G

Giacomo Carollo, MSc - Psychology

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Published Research Related To This Trial

The clinical effects of digital cognitive behavioral therapy for insomnia in a heterogenous study sample: results from a randomized controlled trial.

Jennifer Schuffelen, Leonie F Maurer, Noah Lorenz...

https://pubmed.ncbi.nlm.nih.gov/37428712