SleepUp Digital CBTi-based Platform for Insomnia

Summary

Cognitive-Behavioral Therapy for insomnia (CBTi) is a well-established therapeutic intervention for insomnia. SleepUp provides a digital therapeutics platform based on CBTi and additional features. This clinical trial aims at analyzing the efficacy of the CBTi-based platform offered by SleepUp in reducing symptoms of insomnia and will be conducted in 2 phases.

Phase 1

The sample will be composed of 160 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in four groups:

* Standard CBTi (CBTi-S): This treatment consists of an eight-week treatment composed by weekly and structure appointments with board-certified sleep psychologists. The appointments will be made remotely (video calls with psychologists).
* Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral
* Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
* Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.

All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.

Phase 2

This phase will comprise 120 individuals, both males and females, from 20 to 60 years old, with insomnia symptoms considered as at least mild. Those who accept to participate will be randomized and distributed in three groups:

* Minimal intervention - Sleep hygiene (MI-SH): This group will receive an educational program on sleep hygiene through the SleepUp app. Its content covers topics that are also covered in the online CBTi sessions. This procedure is more adequate as a control than the commonly used no treatment or waiting list controls, due to the behavioral
* Online CBTI (CBTI-O): This group will receive access to an eight-weeks CBTi-based treatment through the SleepUp app. The participants of this group will receive interventions equivalent to the standard in-person CBTi, but provided through a digital platform.
* Online CBTi + additional features (CBTi-O+): This group will have access to the complete premium version of SleepUp platform. It includes those presented in the CBTi-O group and other therapeutic and complementary features (including meditation audios and videos, mindfulness therapy, relaxation soundtracks, sleep hygiene tips, virtual assistant, and telehealth.

All participants in all groups will be assessed periodically throughout the eight weeks of intervention with standard sleep questionnaires and sleep logs. Equivalent intervals will be applied to the MI-SH group.

Conditions

• Insomnia
• Sleep Disorder
• Sleep Hygiene

Interventions

BEHAVIORAL

Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies

The CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks.

BEHAVIORAL

Regular Cognitive Behavioural Therapy for Insomnia

This is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls.

BEHAVIORAL

Sleep hygiene - minimal intervention

It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by SleepUp app.

Sponsors & Collaborators

• SleepUp Tecnologia em Saúde Ltda

  lead INDUSTRY

Principal Investigators

• Gabriel N. Pires, PhD · Universidade Federal de São Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-19

Primary Completion

2025-11-18

Completion

2026-12-01

Countries

• Brazil

Study Locations