Sleep and Blankets
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 672
- 试验地点
- 1
- 主要终点
- Insomnia Severity
研究概览
简要总结
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.
详细描述
BACKGROUND Sleep problems are particularly common among adolescents and young adults, a developmental period characterized by biological, psychological, and social changes that increase vulnerability to insomnia. In Denmark, youth aged 16-24 report the highest prevalence of sleep difficulties, and similar trends are seen internationally. Short or disturbed sleep is linked not only to daytime fatigue, impaired academic performance, and social difficulties, but also to increased risk of stress-related disorders, anxiety, depression, and later chronic insomnia. Despite these risks, existing treatment options remain limited. Cognitive-behavioral therapy for insomnia (CBT-I) is effective but resource-intensive, while pharmacological treatments carry risks of side effects and dependency. Safe, accessible, and scalable non-pharmacological alternatives are urgently needed.
Special blankets represent one such potential intervention. These blankets can be designed to stimulate tactile and proprioceptive systems, which may reduce hyperarousal, promote relaxation, and regulate stress-related mechanisms. Preliminary observations suggest beneficial effects on sleep initiation and maintenance, as well as reductions in anxiety and stress. However, robust randomized controlled trials (RCT) in general youth populations with clinically relevant insomnia are lacking.
AIMS AND HYPOTHESES
Primary aim Aim 1: To test the efficacy of different blankets on insomnia severity (primary outcome) in adolescents and young adults with insomnia.
Exploratory aims Aim 2: To test the effect of different blankets on actigraphy-based sleep (sleep efficiency, total sleep time and wake after sleep onset) in a sub-group of adolescents and young adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between 16 and 24 years old
- •Participants must have a score on the Insomnia Severity Index (ISI) above 10.
排除标准
- •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.
研究组 & 干预措施
Group 1 (Blanket A)
Blanket A to be used in 4 weeks (Phase 1 - RCT) and the opportunity for additional 8 weeks (Phase 2 - open trial)
干预措施: Special blanket (Device)
Group 2 (Blanket B)
Blanket B to be used in 4 weeks (Phase 1 - RCT) and the opportunity for additional 8 weeks (Phase 2 - open trial)
干预措施: Different special blanket (Device)
Group 3 (observational)
Sleep with their own blanket throughout the both Phase 1 and Phase 2
结局指标
主要结局
Insomnia Severity
时间窗: Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.
Insomnia Severity Index (ISI) will be used to assess the severity of insomnia symptoms. The ISI is a brief self-report instrument consisting of seven items that evaluates the severity of sleep-onset, sleep maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and level of distress caused by the sleep problem. This corresponds in part to the diagnostic criteria of insomnia. Zero is the minimum value and equivalent to no insomnia and 28 is the maximum value and indicates clinical insomnia in severe degree.
Insomnia Severity
时间窗: Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.
Insomnia Severity Index (ISI) will be used to assess the severity of insomnia symptoms. The ISI is a brief self-report instrument consisting of seven items that evaluates the severity of sleep-onset, sleep maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and level of distress caused by the sleep problem. This corresponds in part to the diagnostic criteria of insomnia. Zero is the minimum value and equivalent to no insomnia and 28 is the maximum value and indicates clinical insomnia in severe degree.
次要结局
- Actigraphy-based sleep(Baseline (T1) and Week 4 (T3))
- Diurnal salivary cortisol(Baseline (T1) and Week 4 (T3))
- Stress(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Depression(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Anxiety(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Cognitive impairment(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Daytime sleepiness(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Health related quality of life(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Mental well-being(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Background information(Baseline (T1))
- Health-related behaviors(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Sleep arousal(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Circadian predispositions(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Credibility/Expectancy(Baseline (T1))
- Questionnaire on evening activity, adherence and user experience(Week 2 (T2), Week 4 (T3), Week 12 (T4))
- The Pittsburgh Sleep Quality Index(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Actigraphy-based sleep(Baseline (T1) and Week 4 (T3))
- Diurnal salivary cortisol(Baseline (T1) and Week 4 (T3))
- Stress(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Depression(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Anxiety(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Cognitive impairment(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Daytime sleepiness(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Health related quality of life(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Mental well-being(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Background information(Baseline (T1))
- Health-related behaviors(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Sleep arousal(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Circadian predispositions(Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.)
- Credibility/Expectancy(Baseline (T1))
- Questionnaire on evening activity, adherence and user experience(Week 2 (T2), Week 4 (T3), Week 12 (T4))
研究者
Ali Amidi
Associate professor
University of Aarhus