Attention-deficit HyperactivityNCT06194162
Weighted Blankets for Sleep Disturbance Among Children With ADHD
A study testing Weighted blanket and Non-weighted blanket in people with Attention-deficit Hyperactivity and Attention Deficit Hyperactivity Disorder, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial summary
Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders
- What is being tested?
- Weighted blanket and Non-weighted blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 340 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Signed informed consent.
- Age 5-12 years (both included) at randomization.
- Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
- Comorbidities are allowed.
- Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
- If on ADHD medication or/and melatonin/sleep medication the dose must be stable, at least two weeks prior to enrollment.
- The child and caregiver have adequate mastery of the Danish language.
Who cannot join
- Have used any type of medical device class 1 weighted blanket before.
- Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
- Another member of the household enrolled in the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
The Parker Institute, Bispebjerg and Frederiksberg Hospital
Frederiksberg, 2000
Elisabeth Ginnerup-Nielsen
About this study
Official title: Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.
Read the detailed description
Over the past decade, interest in the relationship between sleep difficulties and ADHD has increased, with evidence showing that sleep problems are very common among school children with ADHD, affecting nearly three-quarters. Sleep problems may worsening daytime behaviors and may also affect the overall wellbeing of the family, leading to poorer parental mental health and higher stress. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time.
The study is designed as a superiority trial: a parallel group, randomised controlled trial, where participants are randomised to one of two study arms 1:1. The sample consists of 340 participants, divided into two groups. After randomisation each participant will stay in their assigned treatment arm during the entire study. For each study participant, the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention. Thereafter participants will be followed through national health registers.
The trial will take place at the Child and Adolescent Mental Health Center, Mental Health Services in the Capital Region of Denmark. This center is providing assessment and treatment of children and adolescents with psychiatric disorders.
- Conditions
- Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Sleep Disturbance, Attention Deficit Disorder, Hyperkinetic Conduct Disorder
- Being tested
- Weighted blanket, Non-weighted blanket
- Keywords
- ADHD, weighted blanket, Children, Randomised controlled trial, Sleep Disturbance, ADD, Functional impairment
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted blanketDevice
The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Participants will be asked to choose one out of at least three different weighted blankets, each with different weight classes. The choice of weighted blanket is solely taken by the participant after having tried all five blankets.
Adherence to the weighted blanket intervention is defined as reported use 60 % of the intervention period.
Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.
Non-weighted blanketDevice
The control comparator will receive a sham intervention in the form of a non-weighted blanket as an add on to usual care. Participants will be asked to choose one out of two different sham blankets.
Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication.
| Study group | Role | What they receive |
|---|---|---|
| Weighted blanket | Experimental | The intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Receives: Device: Weighted blanket |
| Non-weighted blanket | Sham comparator | The control comparator group will receive a sham intervention in the form of a non-weighted blanket. as an add on to usual treatment. Receives: Device: Non-weighted blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total sleep time (average minutes per day)
Total sleep time (TST) is defined as the time of total sleep episode minus the awake time (the entire time spent sleeping) and reported in minutes per day. TST per day will be measured using actigraphy in form of MotionWare 8 (The MotionWare 8®-CamNtech MotionWare).
Measured: Week 0 and 4
Secondary outcomes (9)
Changes in functional impairment
Functioning impairment will be measured using Weiss Functional Impairment Rating Scale (WFIRS-P). The WFIRS-P is a 50-item scale assessment tool where caregivers rate the impact of their child's emotional or behavioural problems in the previous month on six separate domains: (A) Family (ten items); (B) School and learning; (C) Life skills; (D) Child's self-concept; (E) Social activities; and (F) Risky activities. Each item is rated on a four-point scale from 0 ('never or not at all') to 3 ('very often or very much') or rated as 'not applicable'. The instrument uses a likert scale such that any item rating 2 or 3 is clinically impaired. The mean of all scored items for each domain will be calculated. Furthermore, a single overall WFIRS-P score will also be calculated as the average of the six domain scores.
Measured: Week 0 and 4
Changes in sleep onset latency (average minutes per day)
Sleep onset latency (SOL) refers to the period of time between turning lights out to go to sleep and falling asleep. SOL will be measured using actigraphy which includes a button that should be pressed by a caregiver when the lights are turned off. SOL will be reported as minutes per day.
Measured: Week 0 and 4
Changes in number of awakenings (numbers per night)
Wake after sleep is defined as number of minutes scored as wake during sleep period and will be measured using actigraphy.
Measured: Week 0 and 4
Changes in sleep efficiency (percentage)
Sleep efficiency (SE) is measured using actigraphy and is the actual sleep time expressed as a percentage of the total time in bed (the time elapsed between "lights out" and "get up time"). SE will be reported as minutes per day.
Measured: Week 0 and 4
Changes in ADHD core symptoms (score point)
ADHD core symptoms will be measured with Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) parent version. It is a 26-item questionnaire including the 18 original ADHD-RS-IV items supplied with 8 conduct problem items. All items are rated on a 4-point Likert scale (0-3), where 0 represents never or rarely, 1 is sometimes, 2 is often, and 3 is very often. From the item scores, a total score ranging 0-78 will be calculated. Further, three sub-scores will be calculated; inattentive scale: range 0-27, hyperactive/impulsive scale: range 0-27, and conduct scale: range 0-24.
Measured: Week 0 and 4
Changes in parental stress (score point)
Changes in parental stress is measured by the Parental Stress Scale (PSS). The PSS is an 18-item questionnaire assessing parents' feelings about their parenting role, exploring both positive aspects (e.g. emotional benefits, personal development) and negative aspects of parenthood (e.g. demands on resources, feelings of stress). Parents can agree or disagree in terms of their typical relationship with their child or children. Responses are scored as follows: strongly disagree, disagree, undecided, agree, strongly agree. To compute the parental stress score, items 1, 2, 5, 6, 7, 8, 17, and 18 should be reversely scored as follows: (1=5) (2=4) (3=3) (4=2) (5=1). The item scores are then summed. Parental stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
Measured: Week 0 and 4
Changes in child quality of life (score point)
Child quality of life will be measured using The World Health Organisation- Child Well-Being Index (WHO-5). The WHO-5 Child Wellbeing Index is a simple self-reported measure of children's psychological wellbeing. The tool consists of five statements describing a positive state. The child is asked to say how often they felt that way during the past two weeks, by selecting one of the following options: All the time, Often, Sometimes, Rarely or Never.
Measured: Week 0 and 4
Adverse events (Number of participants with adverse events)
Number of participants with adverse events (AE).
Measured: During intervention
Serious adverse events (Number of participants with serious adverse events)
Number of participants with serious adverse events (SAE).
Measured: During intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start1 Jan 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention-deficit HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomised controlled trial with two parallel groups. Participants will be randomly assigned 1:1 into two groups using computer-generated random numbers. The allocation sequence will be stratified by age (5-8 years vs 9-12 years), ADHD medication (yes vs no) and use of melatonin/sleep medication (yes vs no).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Responsible party
- Principal investigator, Ina Olmer Specht, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Ina O. Specht, Ph.d., Principal investigator, Research Unit for Dietary Studies, The Parker Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194162
- Sponsor's protocol ID
- Sweet Dreams
- Status last verified
- Aug 2026
- First submitted
- 21 Nov 2023
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rohde JF, Ginnerup-Nielsen E, Larsen SC, Tjott C, Christensen R, Heitmann BL, Waehrens EE, Pagsberg AK, Specht IO. Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial. BMC Psychiatry. 2025 Apr 8;25(1):345. doi: 10.1186/s12888-025-06768-6.
PubMed 40200167
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Weighted Blankets on Sleep Disturbance Among Children With Attention Deficit Hyperactivity Disorders: A Pragmatic Randomised Trial
- ClinicalTrials.gov ID
- NCT06194162
- Acronym / sponsor ID
- Sweet Dreams
- Conditions
- Attention-deficit Hyperactivity, Attention Deficit Hyperactivity Disorder, Neurodevelopmental Disorders, Sleep Disturbance, Attention Deficit Disorder, Hyperkinetic Conduct Disorder
- Keywords
- ADHD, weighted blanket, Children, Randomised controlled trial, Sleep Disturbance, ADD, Functional impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many children with ADHD suffer from sleep disorders and dysfunction, which may affect development and well-being. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time. Results will support health- and social professionals who are involved in the treatment of children with ADHD.
Detailed description
Over the past decade, interest in the relationship between sleep difficulties and ADHD has increased, with evidence showing that sleep problems are very common among school children with ADHD, affecting nearly three-quarters. Sleep problems may worsening daytime behaviors and may also affect the overall wellbeing of the family, leading to poorer parental mental health and higher stress. According to the clinicians, some children find relief from restlessness and difficulty sleeping by using weighted blankets which have been proposed to reduce restlessness and stress via sensory integration and to calm the child by stimulating the sense of touch, muscles and joints. However, evidence for an effect on sleep is scarce, and only one RCT has investigated the effect of weighted blankets among children with ADHD. Using a RCT design, the aim is to investigate the effect on sleep disorders and dysfunction in children with ADHD aged 5-12 years by (1) using a weighted blanket during night and daytime in addition to usual treatment, compared to (2) usual treatment and a non-weighted sham blanket, with the primary outcome being differences in total sleep time.
The study is designed as a superiority trial: a parallel group, randomised controlled trial, where participants are randomised to one of two study arms 1:1. The sample consists of 340 participants, divided into two groups. After randomisation each participant will stay in their assigned treatment arm during the entire study. For each study participant, the active intervention period is 28 days with assessment of primary and secondary outcomes at baseline and after 28 days of intervention. Thereafter participants will be followed through national health registers.
The trial will take place at the Child and Adolescent Mental Health Center, Mental Health Services in the Capital Region of Denmark. This center is providing assessment and treatment of children and adolescents with psychiatric disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is designed as a randomised controlled trial with two parallel groups. Participants will be randomly assigned 1:1 into two groups using computer-generated random numbers. The allocation sequence will be stratified by age (5-8 years vs 9-12 years), ADHD medication (yes vs no) and use of melatonin/sleep medication (yes vs no).
| Arm | Type | Receives |
|---|---|---|
| Weighted blanket | Experimental | Device: Weighted blanketThe intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. |
| Non-weighted blanket | Sham comparator | Device: Non-weighted blanketThe control comparator group will receive a sham intervention in the form of a non-weighted blanket. as an add on to usual treatment. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Signed informed consent.
- Age 5-12 years (both included) at randomization.
- Primary diagnosis of ADHD according to ICD-10 code F90.0, F90.1, F90.9 or F98.8.
- Comorbidities are allowed.
- Participated in a usual care sleep hygiene program managed by clinicians without effect within 6 months prior to enrollment.
Key exclusion criteria (3 listed)
- Have used any type of medical device class 1 weighted blanket before.
- Any diagnosed diseases that markedly compromises the participant's ability to adhere to the intervention (like mental retardation, severe underweight, chronic respiratory or circulatory conditions, surgical implants, osteoporosis).
- Another member of the household enrolled in the trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted blanketThe intervention group will receive a weighted blanket classified as a medical device class 1 as an add on to usual treatment. Participants will be asked to choose one out of at least three different weighted blankets, each with different weight classes. The choice of weighted blanket is solely taken by the participant after having tried all five blankets. Adherence to the weighted blanket intervention is defined as reported use 60 % of the intervention period. Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication. | Device | Weighted blanket |
| Non-weighted blanketThe control comparator will receive a sham intervention in the form of a non-weighted blanket as an add on to usual care. Participants will be asked to choose one out of two different sham blankets. Usual treatment as part of standard care for children with ADHD, which can consist of sleep hygiene, psychoeducation, cognitive behavioral theory, medications such as melatonin or ADHD medication. | Device | Non-weighted blanket |
Primary outcome
Changes in total sleep time (average minutes per day)
Time frame: Week 0 and 4
Total sleep time (TST) is defined as the time of total sleep episode minus the awake time (the entire time spent sleeping) and reported in minutes per day. TST per day will be measured using actigraphy in form of MotionWare 8 (The MotionWare 8®-CamNtech MotionWare).
9 secondary outcomes
Changes in functional impairment
Time frame: Week 0 and 4
Changes in sleep onset latency (average minutes per day)
Time frame: Week 0 and 4
Changes in number of awakenings (numbers per night)
Time frame: Week 0 and 4
Changes in sleep efficiency (percentage)
Time frame: Week 0 and 4
Changes in ADHD core symptoms (score point)
Time frame: Week 0 and 4
Changes in parental stress (score point)
Time frame: Week 0 and 4
Changes in child quality of life (score point)
Time frame: Week 0 and 4
Adverse events (Number of participants with adverse events)
Time frame: During intervention
Serious adverse events (Number of participants with serious adverse events)
Time frame: During intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Derived from this study: PubMed 40200167Rohde JF, Ginnerup-Nielsen E, Larsen SC, Tjott C, Christensen R, Heitmann BL, Waehrens EE, Pagsberg AK, Specht IO. Impact of weighted blankets on sleep disturbance among children with attention deficit hyperactivity disorders (ADHD): study protocol for a pragmatic randomised controlled trial. BMC Psychiatry. 2025 Apr 8;25(1):345. doi: 10.1186/s12888-025-06768-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ina O. Specht, Ph.d. principal investigator
Research Unit for Dietary Studies, The Parker Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted blanket and Non-weighted blanket in people with Attention-deficit Hyperactivity and Attention Deficit Hyperactivity Disorder, run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ina O. Specht, Ph.d. (+45 51197904, ina.olmer.specht@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total sleep time (average minutes per day) (time frame: Week 0 and 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06194162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.