{
    "abstract": "Sleep disturbances are common among children with attention deficit hyperactivity disorder (ADHD) and may affect well-being. Weighted blankets have been proposed to reduce restlessness via sensory integration by stimulating the tactile and proprioceptive senses. Evidence for an effect on sleep and functional impairment is however sparse. We here describe a trial which aims to compare the effect of using a weighted blanket relative to a non-weighted sham blanket on total sleep time in children with ADHD.\nA parallel group randomised controlled trial will be conducted. We anticipate enrolling 340 patients from six public and one private child and adolescent mental health centres in the Capital Region of Denmark. Patients are aged 5 to 12 years, diagnosed with ADHD or attention deficit disorders (ADD) according. Patients will be randomly allocated (1:1) to either a weighted or non-weighted blanket as add-on to usual treatment. The allocation sequence will be stratified by age (5-8 years vs. 9-12 years), ADHD medication (yes vs. no) and use of sleep medication (yes vs. no). Patients in both groups will be guided in using the weighted- or non-weighted blanket every night and at least once daily for four weeks. The primary outcome will be change from baseline to end of trial 4 weeks from baseline in average total night sleep time, assessed with sleep actigraphy. Secondary outcomes are child functioning impairment, sleep onset latency, number of awakenings, sleep efficiency, ADHD core symptoms, quality of life, and parental quality of life and stress. Main analyses for the efficacy outcomes will be assessed using intention-to-treat analysis. All results from statistical analyses on key secondary endpoints will be accompanied by two-sided 95% CIs and corresponding p values.\nThe implication of this trial holds the potential to have substantial impact on clinical practices and health policy. The research findings could establish an evidence-based, non-pharmacological approach for children with ADHD and sleep problems.\nThe study protocol is registered on ClinicalTrials.gov no. NCT06194162. Registered on January 8, 2024.\nVersion 1.0.",
    "authors": [
        {
            "affiliation": "Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, Frederiksberg, 2000, Denmark. jeanett.friis.rohde@regionh.dk.",
            "firstname": "Jeanett Friis",
            "initials": "JF",
            "lastname": "Rohde"
        },
        {
            "affiliation": "Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, Frederiksberg, 2000, Denmark.",
            "firstname": "Elisabeth",
            "initials": "E",
            "lastname": "Ginnerup-Nielsen"
        },
        {
            "affiliation": "Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, Frederiksberg, 2000, Denmark.\nSection for General Practice, Department of Public Health, Copenhagen University, Copenhagen, Denmark.",
            "firstname": "Sofus Christian",
            "initials": "SC",
            "lastname": "Larsen"
        },
        {
            "affiliation": "Child and Adolescent Mental Health Centre, Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, Denmark.",
            "firstname": "Camilla",
            "initials": "C",
            "lastname": "Tjott"
        },
        {
            "affiliation": "Research Unit of Rheumatology, Department of Clinical Research, University of Southern Denmark, Odense University Hospital, Odense, Denmark.\nSection for Biostatistics and Evidence-Based Research, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.",
            "firstname": "Robin",
            "initials": "R",
            "lastname": "Christensen"
        },
        {
            "affiliation": "Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, Frederiksberg, 2000, Denmark.\nSection for General Practice, Department of Public Health, Copenhagen University, Copenhagen, Denmark.",
            "firstname": "Berit Lilienthal",
            "initials": "BL",
            "lastname": "Heitmann"
        },
        {
            "affiliation": "Department of Public Health, University of Southern Denmark, Odense, Denmark.\nOccupation-Centered Occupational Therapy, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Nordre Fasanvej 57, Frederiksberg, 2000, Denmark.",
            "firstname": "Eva Ejlersen",
            "initials": "EE",
            "lastname": "Waehrens"
        },
        {
            "affiliation": "Child and Adolescent Mental Health Centre, Copenhagen University Hospital - Mental Health Services CPH, Copenhagen, Denmark.\nDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.",
            "firstname": "Anne Katrine",
            "initials": "AK",
            "lastname": "Pagsberg"
        },
        {
            "affiliation": "Research Unit for Dietary Studies, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, Frederiksberg, 2000, Denmark.\nSection for General Practice, Department of Public Health, Copenhagen University, Copenhagen, Denmark.",
            "firstname": "Ina Olmer",
            "initials": "IO",
            "lastname": "Specht"
        }
    ],
    "conclusions": null,
    "copyrights": "\u00a9 2025. The Author(s).",
    "doi": "10.1186/s12888-025-06768-6",
    "journal": "BMC psychiatry",
    "keywords": [
        "ADHD",
        "Randomised controlled trial",
        "Sensory integration.",
        "Sleep",
        "Weighted blanket"
    ],
    "methods": null,
    "publication_date": "2025-04-09",
    "pubmed_id": "40200167\n37495084\n22889337\n16938146\n17890980\n30927228\n23294623\n18391142\n31446370\n22236629\n21852983\n36239408\n34144449\n25871605\n20662681\n36824380\n34184958\n37452697\n23303884\n18929686\n25127644\n25961599\n31428003\n9989370\n28220338\n18775056\n32807191\n20405245\n11491192\n10146874\n37170796\n34016442",
    "results": null,
    "title": "Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial.",
    "xml": "<Element 'PubmedArticle' at 0x788503910cc0>"
}