Special blankets to improve sleep for 16–24-year-olds
Sleep and Blankets
This project will test whether special tactile or weighted blankets help 16–24‑year‑olds with insomnia sleep better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 672 (estimated) |
| Ages | 16 Years to 24 Years |
| Sex | All |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT07181577 on ClinicalTrials.gov |
What this trial studies
Young people aged 16–24 with clinically relevant insomnia (Insomnia Severity Index >10) are randomized to use different types of special blankets. Sleep outcomes are measured using the Insomnia Severity Index, objective actigraphy monitoring, and questionnaires on anxiety, stress, and daytime functioning. Key exclusions include neurological or diagnosed sleep disorders, circulatory or respiratory disease, pregnancy, shift work, recent prior special-blanket use, and insufficient Danish proficiency. The intervention is delivered at the Department of Psychology and Behavioural Sciences at Aarhus University and compared across blanket types over a defined follow-up period.
Who should consider this trial
Good fit: Ideal candidates are Danish-speaking 16–24‑year‑olds with an Insomnia Severity Index score above 10 and no major neurological, circulatory, respiratory, pregnancy, or diagnosed sleep disorder.
Not a fit: People with diagnosed medical sleep disorders (e.g., sleep apnea or narcolepsy), significant neurological or affective disorders, current shift workers, pregnant individuals, or those who used a special blanket within the past five years are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide a simple, safe, and scalable non-drug option to reduce insomnia symptoms in young people.
How similar studies have performed: Preliminary observations and small-scale reports suggest benefits for sleep initiation and reduced anxiety, but robust randomized controlled trials in general youth populations are currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be between 16 and 24 years old * Participants must have a score on the Insomnia Severity Index (ISI) above 10. Exclusion Criteria: * Presence of neurological disorders known to influence or be related to poor sleep including affective disorders and diagnosed medical sleep disorders (e.g., sleep apnea, narcolepsy) * Circulatory or respiratory disease * Pregnancy, shift or night work * Prior use of special blanket (within the past five years) * Insufficient Danish proficiency.
Where this trial is running
Aarhus
- Department of Psychology and Behavioural Sciences, Aarhus University — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Ali Amidi, Associate Professor
- Email: ali@psy.au.dk
- Phone: +4587165305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.