Clinical trial Recruiting at 1 site Interventional Ages 16 to 24

Special blankets to improve sleep for 16–24-year-olds

Official title: Sleep and Blankets

Run by Aarhus University Hospital · NCT07181577 · Data updated 2026-11-12

This project will test whether special tactile or weighted blankets help 16–24‑year‑olds with insomnia sleep better.

Quick facts

Study typeInterventional
Ages16 Years to 24 Years
SexAll
Enrollment672 (estimated)
SponsorAarhus University Hospital
Academic / other
Locations1 site (Aarhus)
StatusRecruiting
StartedOctober 15, 2025
Main results expectedDecember 15, 2026
Study endsFebruary 1, 2027
Registry record updatedDecember 17, 2025
Trial IDNCT07181577 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Department of Psychology and Behavioural Sciences, Aarhus University
    Aarhus, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.