A robot intervention for adults with ADHD and insomnia
| ISRCTN | ISRCTN11007746 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11007746 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Karlstad University |
| Funder | Karlstads universitet |
- Submission date
- 29/03/2023
- Registration date
- 29/03/2023
- Last edited
- 09/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The study looks at individual effects and experiences of a sleep robot intervention in adults with ADHD and insomnia. Different methods to collect data were used such as sleep diaries, wrist actigraphy, questionnaires, and individual interviews.
Who can participate?
Adults aged over 18 years with ADHD and insomnia.
What does the study involve?
A three-week at-home intervention with the Somnox sleep robot.
What are the possible benefits and risks of participating?
The main possible benefit was reduced insomnia symptoms. Risks with participation included the individuals’ experiences of invasion of privacy when sensitive questions about psychiatric symptoms and well-being are asked. However, the outcome measures of the current study have been used in many studies without any known complications concerning the character of the questions.
Where is the study run from?
Karlstad University (Sweden).
When is the study starting and how long is it expected to run for?
December 2020 to June 2022.
Who is funding the study?
Karlstad University (Sweden)
Who is the main contact?
Mrs Siri Jakobsson Støre
siri.store@kau.se
Contact information
Principal investigator
Karlstad University
Department of Social and Psychological Studies
Karlstad
65188
Sweden
 ORCID ID |
0000-0001-5749-0774 |
|---|---|
| Phone | +46 733019195 |
| siri.store@kau.se |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed-methods study with an explanatory sequential design |
| Secondary study design | Non randomised study |
| Participant information sheet | 43406 PIS (in Swedish).pdf |
| Scientific title | A robot intervention for adults with ADHD and insomnia - A mixed-method study |
| Study objectives | The aims are to assess whether a three-week sleep robot intervention have individual effects in adults with adhd and insomnia, and how initial results can be understood in light of participants’ experiences with the robot. |
| Ethics approval(s) | Approved 20/01/2021, Swedish Ethical Review Authority (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: DNR 2020-06975 |
| Health condition(s) or problem(s) studied | Insomnia |
| Intervention | A three-week sleep robot intervention with the Somnox sleep robot. Assessments were conducted daily for six weeks (sleep diary and wrist actigraphy), and pre- and post-intervention (questionnaires). Recruitment happened through the university webpage and social media. Screening was conducted via phone (60-90 minutes). Participants were individually trained in how to use the sleep robot for 10-15 minutes. The intervention lasted for 21 days in participants’ homes. Participants were encouraged to use the robot each evening/night of the intervention phase. Daily subjective sleep measurements were obtained with a sleep diary for six consecutive weeks (two baseline weeks, three intervention weeks, and one post-intervention week) (approximately 5 minutes). The same sleep variables were also obtained objectively with wrist actigraphy for two weeks of the study: week 1 (baseline) and week 3 (intervention). Additionally, participants answered questionnaires at pre-intervention, mid-intervention, post-intervention, and 1-month follow-up (approximately 10 minutes). |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Somnox sleep robot |
| Primary outcome measure(s) |
Sleep onset latency and wake after sleep onset: the Consensus Sleep Diary (daily for weeks 1-6 of the study) and actigraphy (week 1 and week 3). |
| Key secondary outcome measure(s) |
1. Total sleep time and sleep efficiency: the Consensus Sleep Diary (daily for weeks 1-6 of the study) and actigraphy (week 1 and week 3). |
| Completion date | 01/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 6 |
| Total final enrolment | 6 |
| Key inclusion criteria | 1. Speak Swedish fluently 2. 18 years+ of age 3. Previously diagnosed with ADHD 4. Meet the diagnostic criteria of insomnia |
| Key exclusion criteria | 1. Meet the diagnostic criteria of another untreated sleep disorder 2. Meet the diagnostic criteria of another current psychiatric disorder |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 01/04/2022 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Karlstad
65188
Sweden
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Siri Jakobsson Støre, siri.store@kau.se |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/09/2023 | 09/10/2023 | Yes | No | |
| Dataset | 20/06/2023 | No | No | ||
| Participant information sheet | in Swedish | 29/03/2023 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 20/06/2023 | No | No | ||
| Protocol file | 20/06/2023 | No | No | ||
| Protocol file | 20/06/2023 | No | No | ||
| Protocol file | 20/06/2023 | No | No | ||
| Statistical Analysis Plan | 20/06/2023 | No | No | ||
| Statistical Analysis Plan | 20/06/2023 | No | No |
Additional files
- 43406 PIS (in Swedish).pdf
- in Swedish
- ISRCTN11007746_PROTOCOL_English.pdf
- Protocol file
- ISRCTN11007746 _PROTOCOL_Swedish.pdf
- Protocol file
- ISRCTN11007746_PROTOCOL_Adjusted_English.pdf
- Protocol file
- ISRCTN11007746_PROTOCOL_Adjusted_Swedish.pdf
- Protocol file
- ISRCTN11007746_PROTOCOL_English.pdf
- Statistical Analysis Plan
- ISRCTN11007746 _PROTOCOL_Swedish.pdf
- Statistical Analysis Plan
- ISRCTN11007746 dataset.xlsx
- Dataset
Editorial Notes
09/10/2023: Publication reference added.
20/06/2023: Protocols, statistical analysis plan and dataset uploaded.
29/03/2023: Trial's existence confirmed by Swedish Ethical Review Authority (Etikprövningsmyndigheten)
