hiPanya will be studied in this research with a healthy, non-clinical sample from the general population, which is not considered to have an increased need for medical or therapeutic intervention.
Conditions
Interventions
Group 1: The subject of the study is the use of the smartphone application hiPanya:
Parents (= participants) can use hiPanya freely. There is no fixed usage requirement. However, regular use of hiPan
Sponsors
Medigital GmbH
Eligibility
Sex/Gender
All
Age
3 Years to 11 Years
Inclusion criteria
Inclusion criteria: -Age of the child: 3;0 to 11;11 years - The child's sleep situation is perceived as challenging by the participant - Willingness and resources of the participant to actively cooperate in this study - Internet connection in the family, smartphone, and active email address - Written consent from the legal guardians and verbal assent from the child for participation in the study
Exclusion criteria
Exclusion criteria: - Diagnosed obstructive sleep apnea or other organic sleep disorders of the child (ICD-10 Code G47.x; self-reported) - Diagnosed non-organic sleep disorders of the child (ICD-10 Code F51.x; self-reported) - Indication of an organic and/or non-organic sleep disorder of the child (An indication is present if there are difficulties falling asleep OR staying asleep OR early morning awakenings AND an impairment of daytime behavior (e.g., daytime sleepiness) for at least one month for at least three nights a week.) - Previous use of hiPanya (Pro version) - Concurrent participation in other studies or other clinical research projects - Concurrent participation in this study with another child
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the total score of the Children's Sleep Habits Questionnaire (CSHQ-DE) between T1, T2, and T3 T1 = Start of the study T2 = 6 weeks after study start T3 = 12 weeks after study start | — |
Secondary
| Measure | Time frame |
|---|---|
| Collection of all secondary outcomes at T1, T2, and T3: - T1 = Start of the study - T2 = 6 weeks after the start of the study - T3 = 12 weeks after the start of the study Secondary outcomes: - All subscales of the CSHQ-DE - German translation of the Bedtime Routines Questionnaire (BRQ) - Kiddy-KINDL; subscales for physical and emotional well-being - German version of the Parental Stress Scale (PSS) Additional outcomes: - Total sleep duration, time to fall asleep, duration and frequency of nighttime awakenings, and daytime sleepiness as recorded in the sleep diary/sleep tracking from the application - Usage behavior based on login data - Adverse events, product defects | — |
Countries
Germany
Contacts
Public ContactMichael Karus
Medigital GmbH
Outcome results
None listed