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

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

March 10, 2025

Primary Completion Date

October 1, 2025

Study Completion Date

March 10, 2026

Conditions
Insomnia ChronicInsomnia
Interventions
BEHAVIORAL

Digital Health Technology for Chronic Insomnia

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

BEHAVIORAL

Treatment as Usual (TAU)

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.

Trial Locations (1)

37129

RECRUITING

Ospedale Borgo Roma - Neurologia B, Verona

All Listed Sponsors
collaborator

Santer Reply S.p.A. Milan, Italy

UNKNOWN

collaborator

daVi Digital Medicine s.r.l. Verona, Italy

UNKNOWN

collaborator

QStep s.r.l. Verona, Italy

UNKNOWN

collaborator

Fondazione RIDE2Med, Milan, Italy

UNKNOWN

lead

Universita di Verona

OTHER