CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 489 enrolled
Drug / intervention
Sleep Optimization +4 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05561829
NCT05561829N/ACompleted

Determination of Optimal Sleep Treatment Elements (The DOSE Project)

University of Aarhus·interventional·Posted Sep 30, 2022·Updated Nov 18, 2025

In Brief

A clinical study evaluating Sleep Optimization, Stimulus Control Therapy, and 3 other interventions for Insomnia Chronic. Completed, enrolled 489 participants across 1 site.

Detailed Summary

Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. By means of the Multiphase Optimization Strategy (MOST), this study aims to investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia. A future study will verify this intervention's effect in a randomized controlled trial (RCT).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark

Timeline

N/ACompletedFinished
2023202420252026
First PostedSep 30, 2022
Enrollment StartSep 8, 2022
Primary CompletionMay 18, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 3.8 years ago

Interventions

Sleep Optimizationbehavioral

Automated digital administration of a sleep optimization module via mobile or web application, lasting approximately six weeks. Based on the participant's situation and needs, sleep restriction, sleep compression, or circadian-rhythm normalization is advised and conducted. The aim is to optimise the participant's sleep efficiency.

Stimulus Control Therapybehavioral

Automated digital administration of a stimulus control therapy module via mobile or web application, lasting approximately six weeks. The aim is to strengthen associations between sleep and the sleep environment and to eliminate conditioning of non-sleep behavior and the sleep environment.

Relaxation Trainingbehavioral

Automated digital administration of a relaxation training module via mobile or web application, lasting approximately six weeks. The aim is to reduce somatic tension and limit intrusive thought processes that interfere with sleep.

Cognitive Therapybehavioral

Automated digital administration of a cognitive therapy module via mobile or web application, lasting approximately six weeks. The aim is to identify, challenge, and modify dysfunctional beliefs about sleep.

Sleep Hygiene Educationbehavioral

Automated digital administration of a sleep hygiene education module via mobile or web application, lasting approximately six weeks. The aim is to identify and modify environmental and lifestyle factors that may interfere with sleep.