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The effects of a sleep robot intervention on sleep, depression, and anxiety in adults with insomnia

The effects of a sleep robot intervention on sleep, depression and anxiety in adults with insomnia - a randomized waitlist-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35134834
Enrollment
44
Registered
2021-07-06
Start date
2021-08-09
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Mental and Behavioural Disorders Insomnia

Interventions

The active intervention group will use a sleep robot (Somnox) at home for three weeks. Assessments will be conducted at baseline, mid-treatment, and post-treatment for both the active intervention gro

Sponsors

Karlstad University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Meets the DSM-5 diagnostic criteria for insomnia disorder as measured by clinical evaluation by a licensed psychologist using the Insomnia severity index (ISI) and the Duke structured clinical interview for sleep disorders (DSISD)

Exclusion criteria

Exclusion criteria: 1. Does not speak Swedish 2. Aged <18 years 3. Meet the criteria for another sleep disorder which they are not adequately treated for 4. Meet the diagnostic criteria for a medical or psychiatric condition that may explain the symptoms of insomnia

Design outcomes

Primary

MeasureTime frame
Insomnia measured with the Insomnia Severity Index at baseline, 10, and 24 days

Secondary

MeasureTime frame
1. Pre-sleep arousal measured with the total score of the Pre-Sleep Arousal Scale at baseline, and 24 days 2. Symptoms of anxiety and depression measured with the total scores from the anxiety and depression scales of the Hospital Anxiety and Depression Scale at baseline, and 24 days 3. Sleep parameters measured with sleep diaries and actigraphy where the values from both will be averaged over a week to compute single summary scores for each of the relevant variables, for the periods -7 to 0 days and 14 to 21 days

Countries

Sweden

Contacts

Public ContactSiri Jakobsson Støre
siri.store@kau.se+46547001117

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026