Information status: [TBD]
Instructions for Use
These Instructions for Use serve the proper use of hiLuno®. Hereinafter referred to as hiLuno®. Please read this information carefully and attentively and follow the instructions contained herein.
For content-related or technical questions, the customer support team is also available during core hours from Monday to Friday (excluding public holidays) between 8:00 and 18:00 via the feedback function in the hiLuno® app or via the service e-mail address kinderschlaf@medice.de. You can also reach us outside our core hours via the feedback function in the app or directly via the service e-mail address kinderschlaf@medice.de. You will receive a response to your enquiry from us within 24 hours at the latest.
Intended purpose of the medical device pursuant to EU Medical Device Regulation 2017/745
The medical device software hiLuno® supports families with children with attention-deficit/hyperactivity disorder (ADHD) and non-organic sleep problems aged approximately 4 to 11 years in dealing with sleep-related challenges in everyday life. By using hiLuno®, parents and other guardians learn to adapt sleep-related behaviours and framework conditions together with their child in an interactive manner. The aim is to improve sleep or sleep satisfaction and to ease everyday family life — not to treat the core symptoms of ADHD itself. [TBD]
Mode of operation
hiLuno® is a guided, digital self-help programme for parents and other guardians of affected children. In addition to psychoeducational content, the application offers evidence-based elements of cognitive behavioural therapy for insomnia (CBT-I), sleep hygiene and behavioural parenting strategies, which are presented among other things through articles, interactive tasks and further features. Practical tools such as sleep tracking, bedtime routines and training plans help to transfer the knowledge acquired into real everyday situations. [TBD]
Through use of the application, parents and other guardians gain a more comprehensive understanding of sleep problems in ADHD and learn how to adapt sleep-related behaviours and bedtime routines in their daily interactions with their child. This has a positive effect on the child's sleep or sleep satisfaction and thus also on family burden — without claiming to treat the core symptoms of ADHD itself. [TBD]
On the basis of specific user inputs during the onboarding process (including questionnaires on life and sleep situation), the application creates an individual training plan. Specific features such as sleep diary, bedtime routine, reminders, feedback loops and optional recording of events with the help of a remote control enable the user to interactively engage with this medical device software. [TBD]
hiLuno® is based on evidence-based elements of cognitive behavioural therapy for insomnia (CBT-I), sleep hygiene and behavioural parenting strategies. [TBD]
Prerequisites for use
Operation of the hiLuno® application, which can be downloaded from the Apple Store and the Google Play Store, requires an internet-capable smartphone or tablet with the Apple iOS operating system (version [TBD] or higher) or Android OS (version [TBD] or higher). hiLuno® can be downloaded via the respective app stores.
Both the operating systems and the application must be updated regularly to ensure proper functioning of the application. In addition, the user must have a valid e-mail programme on the same end device for account creation and verification.
In order to use the content and all functions of the application, users must have a good command of the German language. [TBD]
Note on platform-related accessibility aids: these must be activated before opening the application.
Notes on IT security measures
To prevent unauthorised access to user accounts, we recommend the following security measures:
- Device protection: It is strongly recommended that a PIN code be set for the end device used (or that biometric login functions such as Face ID or fingerprint be used).
- Password selection: When creating a password, it is recommended to choose a strong and unique combination of letters, symbols and numbers. Using the same password for multiple services should be avoided.
- Confidentiality of login credentials: Login credentials must be treated confidentially and must never be shared with others.
- Version updates: It is recommended to always update the operating system (OS) to the latest available version and to always update the app version to the latest available version in the respective store.
Field of application
hiLuno® can be recommended by physicians and psychotherapists as part of a multimodal treatment strategy that takes into account the child's specific care situation. The application can be used, for example, during the diagnostic phase, at the start of a sleep-related intervention in ADHD, or in parallel with pharmacotherapy. Healthcare professionals can also use the application in parallel with classical face-to-face psychosocial interventions such as psychotherapy or group-based parent training. [TBD]
hiLuno® can also be used without prior recommendation by a physician or psychotherapist. In this case, parents or other guardians should seek advice from a physician or psychotherapist before using the application.
Patient profile
The patients are children aged approximately 4 to 11 years with a confirmed diagnosis or suspected diagnosis of ADHD as well as non-organic sleep problems, in whom at least one of the following ICD-10 codes has been established: [TBD]
- F90.x (Hyperkinetic disorders [commonly known as ADHD])
- F98.80 (Attention deficit disorder without hyperactivity [commonly known as ADD])
Optionally or additionally, non-organic sleep disorders (e.g. ICD-10 F51.x) may be present. Organic causes of sleep problems are not within the actual target scope of the application. [TBD]
The child's sleep problems must occur in the family environment, and the current burden requires an intervention. [TBD]
User profile
Users of the hiLuno® application are parents or other guardians of affected children. The children act as patients and the parents or guardians as users of the application. However, children can also be interactively involved in the use of hiLuno®.
Contraindications
No contraindications are known. [TBD]
Nature and duration of use
Use of hiLuno® is effected via a valid activation code (access key), which users must enter or purchase upon first registration in the application. The period of use per activation code is limited to 90 calendar days after first registration. [TBD]
Frequency of use
In principle, there are no spatial or temporal requirements for the use of hiLuno®. It is recommended that the app be used primarily in situations that allow engagement with the content and reflection without unnecessary interruptions, for example in the evening at home. The programme is completed at the user's own pace. Regular use of hiLuno® over the period of 90 days is recommended.
Notes
Please take note of possible side effects and/or interactions as well as further notes, and discuss with your child's physician or therapist whether use of the medical device hiLuno® is suitable for you and your child.
A change to existing medications and/or other treatments of your child should not be made without consulting the child's physician or therapist. You should contact your child's physician or therapist if your child's health condition does not improve over time (several days/weeks) or if it (or your own) acutely deteriorates.
Organic sleep disorders and warning signs
hiLuno® is directed at non-organic, behaviour-related sleep problems. The application is not a diagnostic tool and does not replace medical evaluation. In the event of signs of possible organic causes — e.g. breathing pauses during sleep, severe snoring, unusual nocturnal movement disorders (such as suspected restless legs syndrome) or other alarming symptoms — you should not use the application as a substitute for medical evaluation and should promptly contact your child's physician or therapist. [TBD]
Severe comorbid mental disorders of the child
If your child is affected by other severe comorbid mental or developmental disorders (e.g. autism spectrum disorders, psychoses or intellectual disability), you should decide individually together with your child's physician or therapist on the use of hiLuno®. If you wish to use hiLuno® without prior recommendation by a physician or therapist, you should nevertheless seek advice from an appropriate professional before using the application. [TBD]
Severe comorbid mental disorders of users
If a severe mental disorder is known in your case (e.g. severe substance use, schizophrenia, psychoses) or you are currently suffering from one such that the ability to use hiLuno® effectively could be impaired, you should decide individually together with your child's physician or therapist on the use of hiLuno®. If you wish to use hiLuno® without prior recommendation by a medical professional, you should nevertheless seek advice from an appropriate professional before using the application.
Overwhelm
Although hiLuno® is a guided and digital "step-by-step" programme, you may feel frustrated or disappointed, particularly if putting what you have learned into practice in everyday life does not succeed immediately. In such cases, it is recommended that you interrupt use of hiLuno® and speak with your child's physician or therapist to discuss further use.
Biopsychosocial conditions
hiLuno® addresses the family as a system. To increase the benefit of this application, sufficient time and resources should be available in the family for daily interactions and programme tasks (e.g. bedtime routine, sleep tracking) between you and your child.
Minimum age
The patient group comprises children aged approximately 4 to 11 years. For users (parents and other guardians), the age-related requirements of the Terms of Use apply; users must be of legal age under the applicable law. [TBD]
Side effects
No side effects are known to date. [TBD]
Interactions
No interactions are known to date. [TBD]
If you notice that the child's health condition or your own health condition is deteriorating, discontinue use of the product for a few days and contact your child's physician or therapist if needed. If you notice side effects of the product, contact your child's physician or therapist. You can also report side effects directly. By reporting side effects, you can help ensure that more information about the safety of this medical device is made available. Please send your report of side effects to: kinderschlaf@medice.de
Emergencies
In acute crises or emergencies, please contact your child's physician or therapist immediately or dial the emergency numbers applicable in your country:
Germany: Emergency / ambulance: 112 Police: 110 Crisis helpline: 0800 111 0 111, 0800 111 0 222
Austria: Emergency / ambulance: 144 Police: 133 Crisis helpline: 142
Europe-wide emergency number: 112
Manufacturer
Medigital GmbH Medice-Allee 1 58638 Iserlohn Germany
Software status
These Instructions for Use relate to hiLuno® software version [TBD]. Please check the Apple Store or Google Play Store for the current software version. The current software version of the application can be found in your hiLuno® account or in the medical device information in the app. [TBD]
Information status
[TBD]
Further information
For technical questions, you can contact us by e-mail at kinderschlaf@medice.de. We will also be happy to send you the Instructions for Use by post. Please contact our customer service by e-mail at kinderschlaf@medice.de for this purpose.
Contact
Medigital GmbH
Medice-Allee 1
58638 Iserlohn
E-mail: info-medigital@medice.de
Managing Director: Dr. Felix Lambrecht
Commercial register no. HRB 10758