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Completed

NCT Number: NCT05558865

Effectiveness of a Digital Health Application for People With Insomnia Disorder (Somnovia)

The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.

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Key information

Conditions

Insomnia Disorder Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, 20144, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of chronic insomnia
  • impaired quality of sleep (Insomnia Severity Index Score ≥ 10)

Exclusion criteria

  • none

Treatment and study plan

somnovia

Behavioral

Participants receive access to the digital health application somnovia

Primary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 3 months after randomization

    The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).

Secondary outcomes

  1. Insomnia Severity Index (ISI)

    Time frame: 6 months after randomization

    The ISI is a 7-item patient-reported outcome measure (PROM) assessing the nature, severity, and impact of insomnia on a 5-point Likert scale to rate each item from 0 (no problem) to 4 (very severe problem).

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: 3 months and 6 months after randomization

    The PHQ-9 is a well-validated nine-item self-report questionnaire developed to score each of the nine DSM-IV criteria for major depressive disorder on a 4-point Likert scale, from "0" (not at all) to "3" (nearly every day).

  3. Generalized Anxiety Disorder Assessment (GAD-7)

    Time frame: 3 months and 6 months after randomization

    The GAD-7 is a self-administered patient questionnaire used as a screening tool and severity measure for generalized anxiety disorder (GAD)

  4. Work and Social Assessment Scale (WSAS)

    Time frame: 3 months and 6 months after randomization

    WSAS is a 5-item self-report scale to measure the ability to work in regard to physical, mental and social health as well as age group referenced competence for performance. Each item is rated on a 9-point Likert scale from 0 = "not at all impaired" to 8 = "very severely impaired".

  5. Responder Rate on Insomnia Severity Index

    Time frame: 3 months after randomization

    A Responder is defined as a patient with an improvement of > 6 points on the total score of the Insomnia Severity Index from T0 to T1

  6. Remission Rate on Insomnia Severity Index

    Time frame: 3 months after randomization

    Remission is defined as patients with a total score on the Insomnia Severity Index of < 8

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • University Hospital Freiburg
  • University Hospital Schleswig-Holstein

Registry information

Official study title

Evaluating the Effectiveness of a Digital Therapeutic (Somnovia) for People With Insomnia Disorder - a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 28, 2022
Registry last updated
Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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