Prospective observational study to investigate the health benefits of the smartphone application hiPanya

Conditions: Sleep problems (to be distinguished from sleep disorders as defined by the inclusion and exclusion criteria of this study)

Registration Number: DRKS00034323

Lead Sponsor: Medigital GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 98

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

- 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

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the total score of the Children's Sleep Habits Questionnaire (CSHQ-DE) between T1, T2, and T3<br><br>T1 = Start of the study<br>T2 = 6 weeks after study start <br>T3 = 12 weeks after study start

Secondary Outcome Measures

Name	Time	Method
Collection of all secondary outcomes at T1, T2, and T3:<br>- T1 = Start of the study<br>- T2 = 6 weeks after the start of the study<br>- T3 = 12 weeks after the start of the study<br><br>Secondary outcomes:<br>- All subscales of the CSHQ-DE<br>- German translation of the Bedtime Routines Questionnaire (BRQ)<br>- Kiddy-KINDL; subscales for physical and emotional well-being<br>- German version of the Parental Stress Scale (PSS)<br><br>Additional outcomes:<br>- 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<br>- Usage behavior based on login data<br>- Adverse events, product defects