What this Trial Is About

Purpose The primary aim of this research project is to evaluate whether a special blanket is an effective intervention for improving sleep among young people aged 16-24 with sleep disturbances. Sleep problems are increasingly common among Danish youth, with approximately one in five reporting significant sleep difficulties in the past 14 days. This trend has been rising steadily since 2010 and is mirrored internationally. Sleep disturbances are linked to a wide range of physical and mental health problems, including stress, anxiety, and depression, as well as negative effects on academic performance and social relationships. Early intervention is crucial to prevent chronic insomnia and poor mental health outcomes in adulthood. Current treatments include specialized psychological therapies and medication. However, psychological therapies require extensive time and commitment, and medication carries risks of side effects, tolerance, and dependency, making non-pharmacological, safe, and accessible alternatives necessary. The special blanket is believed to promote relaxation through stimulation of the tactile and proprioceptive systems. Although promising in clinical and pedagogical contexts for certain populations (e.g., children with developmental disorders and adults with neurological conditions), there is limited scientific evidence regarding its efficacy and underlying mechanisms, particularly among youth with sleep disturbances. Methods and Study Design This project is a Phase 1 randomized controlled trial (RCT) assessing the effect of 4 weeks of using a special blanket on sleep problems among young people aged 16-24, as well as the impact on participants' mental and physical health. Additionally, the study investigates possible stress-related mechanisms involved in the use of the special blanket. Following the 4-week intervention, an open-label extension phase of 8 weeks (Phase 2) will explore continued use and acceptability of the blanket. Eligible participants, screened for sleep problems, will be randomly assigned to one of three groups: Group 1: receives a special blanket (Blanket A) for home use over 4 weeks. Group 2: receives another special blanket (Blanket B) for 4 weeks. Group 3 (observation group): no blanket provided but followed for 4 weeks to monitor changes in sleep problems. The 4-week intervention phase (Phase 1) includes baseline (T1, week 0), mid-intervention (T2, week 2), and post-intervention (T3, week 4) online assessments. Sleep disturbances, physical and mental health, and stress-related mechanisms will be measured using validated questionnaires administered through REDCap. The first 40 participants in Groups 1 and 2 will additionally provide saliva samples and wear a circadian rhythm monitor (activity watch). In Phase 2, participants in Groups 1 and 2 may continue using the blanket or revert to their usual bedding. At the end of Phase 2 (T4, week 12), follow-up questionnaires will assess sleep and user experience, including satisfaction, perceived benefits, barriers, and drawbacks of the blanket. Group 3 will then be offered a special blanket for an 8-week trial. Participants The investigators aim to recruit 672 young people aged 16-24 with sleep problems. Inclusion criteria are age 16-24 years and sleep problems measured by Insomnia Severity Index (score \>10). Exclusion criteria are any underlying somatic, psychological, or neurological condition significantly affecting sleep quality; use of medications affecting sleep; pregnancy; shift work or night work; previous use of special blankets for sleep improvement and insufficient Danish language skills (questionnaires in Danish). Significance and Relevance The investigators anticipate that the findings will contribute to the current understanding of the non-pharmacological management of sleep problems, related mental and physical health outcomes, and underlying stress-related mechanisms of special blanket interventions. The results will be relevant to health professionals working with sleep problems, but also to adolescents and younger adults with sleep problems and their parents. New clinical guidelines on sleep problems in children and adolescents recommend non-pharmacological treatments as the first choice, specifically mentioning the potential efficacy of special blankets. The proposed project will help inform further development of such guidelines and related clinical practice. If special blankets are found to be effective in reducing insomnia, they could serve as an inexpensive, easily disseminated, and administered treatment with no known side effects, with the potential to greatly reduce the personal, as well as societal costs of insomnia.

Sleep and Blankets