Sleep and Blankets

NCT07181577 | Recruiting DMC

• 2 other identifiers: 2022-03675311-10-72-90-25
• Study Type: interventional
• Target: 672
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Problems; Insomnia

Keywords

insomnia; sleep; RCT; blankets; actigraphy; sleep problems; sleep quality; young adults; sleep interventions; sleep disturbances; saliva; adolescents

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity

  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.

  Baseline (T1), week 2 (T2), Week 4 (T3), week 12 (T4). To measure change across timepoints.

Secondary Outcomes (16)

• 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.

Study Arms (3)

Group 1 (Blanket A)

EXPERIMENTAL

Blanket A to be used in 4 weeks (Phase 1 - RCT) and the opportunity for additional 8 weeks (Phase 2 - open trial)

Device: Special blanket

Group 2 (Blanket B)

ACTIVE COMPARATOR

Blanket B to be used in 4 weeks (Phase 1 - RCT) and the opportunity for additional 8 weeks (Phase 2 - open trial)

Device: Different special blanket

Group 3 (observational)

NO INTERVENTION

Sleep with their own blanket throughout the both Phase 1 and Phase 2

Interventions

Special blanket DEVICE

Special blanket to be used at home every night in 4 weeks (Phase 1 - RCT) and opportunity for additional 8 weeks (Phase 2 - open trial)

Group 1 (Blanket A)

Different special blanket DEVICE

Different special blanket to be used at home every night in 4 weeks (Phase 1 - RCT) and opportunity for additional 8 weeks (Phase 2 - open trial)

Group 2 (Blanket B)

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants must be between 16 and 24 years old
• Participants must have a score on the Insomnia Severity Index (ISI) above 10.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aarhus University Hospital: lead
• University of Aarhus: collaborator

Study Sites (1)

Department of Psychology and Behavioural Sciences, Aarhus University

Aarhus, 8000, Denmark

RECRUITING

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Central Study Contacts

Ali Amidi, Associate Professor

CONTACT

+4587165305; ali@psy.au.dk

Josefine Tingdal Taube Danielsen, Postdoc

CONTACT

+4587165981; jtd@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: This study uses a randomized controlled trial (RCT) design with three parallel arms to evaluate the effects of a special blanket on sleep problems. Participants are randomly assigned to one of three groups. Group 1: receives Blanket A for home use over 4 weeks. Group 2: receives Blanket B for 4 weeks. Group 3 (observation group): receives no blanket during the same period but completes identical assessments.

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 18, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)