Sleep DisorderNCT05044000
Effect of Deep Propioceptive Stimulation in Prader-Willi Syndrome
A study testing Deep propioceptive stimulation in people with Sleep Disorder and Hyperphagia, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The main objective is to study the effect of deep propioceptive stimulation with a heavy blanket for 2 weeks compared with a placebo blanket on sleep quality and behavior in patients with PWS Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorder, Hyperphagia, Behavior Disorders
- What is being tested?
- Deep propioceptive stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2022to 10 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with PWS genetically confirmed at least 16y old willing to participate and being able to be still in the MRI.
Who cannot join
- Age < 16 years old
- Presence of uncontrolled Obstructive Sleep Apnea (Residual AHI ≥ 30).
- Narcolepsy or other sleep disorders with daily somnolence
- Intolerance to the heavy blanket in spite of previous adaptation sessions
- Active psychopathological disorder that may interfere with sleep
- Use of hypnotic or sleep regulator drugs (change of dose in the last 3 months)
- Contraindications for MRI
- Impossibility to stay still during MRI adquisition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Deep Propioceptive Stimulation on Sleep Disorders, Behavior and Brain Connectivity in Adults with Prader-Willi Syndrome
The main objective is to study the effect of deep propioceptive stimulation with a heavy blanket for 2 weeks compared with a placebo blanket on sleep quality and behavior in patients with PWS
Read the detailed description
Prader-Willi syndrome (PWS) is a genetic disease associated with sleep disorders whose etiology is partly central due to the inherent hypothalamic deficit. It is associated with low cognitive performance and worsening behavior with more impulsivity, tantrums, scratches and obsession for food. Deep propioceptive stimulation with a heavy blanket (HB) stimulates the parasympathetic system and improves the state of anxiety in persons with autism or other causes of intellectual disability and/or psychopathology. To date, there are no studies evaluating the effect of HB on sleep quality or brain activity in persons with PWS. The main objective is to study the effect of HB for 2 weeks compared to a placebo blanket on sleep quality and behavior in patients with SPW.
Methodology: Actigraphy, questionnaires, crossover study in 60 patients with PWS, with HB/placebo blankets (15 days each). Effect of HB on brain connectivity with functional magnetic resonance imaging in 30 patients and 30 controls. Expected results: PWS group will show worse sleep quality and behavior that will improve after using HB. Brain connectivity will be different with/without HB. These favorable changes will help to justify the use of this ecological treatment and its inclusion in the NHS clinical practice guidelines for improving the quality of life of these patients and their caregivers.
- Conditions
- Sleep Disorder, Hyperphagia, Behavior Disorders
- Being tested
- Deep propioceptive stimulation
- Medical subject headings
- Sleep Wake Disorders, Hyperphagia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep propioceptive stimulationDevice
Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket
| Study group | Role | What they receive |
|---|---|---|
| Heavy blanket | Experimental | Patients will start with heavy blanket during 15 days Receives: Device: Deep propioceptive stimulation |
| Non-heavy blanket | Placebo comparator | Patients will start with non-heavy blanket during 15 days Receives: Device: Deep propioceptive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in number of awakenings
measured by actigraphy
Measured: 14 nights
Change in duration of awakenings
minutes measured by actigraphy
Measured: 14 nights
Secondary outcomes (4)
Number of tantrums
caregivers report
Measured: 15 days
number of skin injuries
physical examination by the principal investigator or collaborators
Measured: 15 days
Interest for food
Hyperphagia questionnaire for clinical trials (9 items from 1-4, maximum score 36, more is worse)
Measured: 15 days
Brain connectivity
functional magnetic resonance imaging
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start10 Feb 2022
- Primary completion10 Mar 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Assumpta Caixas, Corporacion Parc Tauli
- Investigators
- Assumpta Caixas, MD, PhD, Principal investigator, Corporacio Sanitaria Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044000
- Sponsor's protocol ID
- Endocrinology Parc Tauli
- Other IDs
- PI21/00459
- Status last verified
- Mar 2025
- First submitted
- 31 Aug 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Propioceptive Stimulation on Sleep Disorders, Behavior and Brain Connectivity in Adults with Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT05044000
- Acronym / sponsor ID
- Endocrinology Parc Tauli
- Conditions
- Sleep Disorder, Hyperphagia, Behavior Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 14 Sep 2021 (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.
The main objective is to study the effect of deep propioceptive stimulation with a heavy blanket for 2 weeks compared with a placebo blanket on sleep quality and behavior in patients with PWS
Detailed description
Prader-Willi syndrome (PWS) is a genetic disease associated with sleep disorders whose etiology is partly central due to the inherent hypothalamic deficit. It is associated with low cognitive performance and worsening behavior with more impulsivity, tantrums, scratches and obsession for food. Deep propioceptive stimulation with a heavy blanket (HB) stimulates the parasympathetic system and improves the state of anxiety in persons with autism or other causes of intellectual disability and/or psychopathology. To date, there are no studies evaluating the effect of HB on sleep quality or brain activity in persons with PWS. The main objective is to study the effect of HB for 2 weeks compared to a placebo blanket on sleep quality and behavior in patients with SPW.
Methodology: Actigraphy, questionnaires, crossover study in 60 patients with PWS, with HB/placebo blankets (15 days each). Effect of HB on brain connectivity with functional magnetic resonance imaging in 30 patients and 30 controls. Expected results: PWS group will show worse sleep quality and behavior that will improve after using HB. Brain connectivity will be different with/without HB. These favorable changes will help to justify the use of this ecological treatment and its inclusion in the NHS clinical practice guidelines for improving the quality of life of these patients and their caregivers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heavy blanket | Experimental | Device: Deep propioceptive stimulationPatients will start with heavy blanket during 15 days |
| Non-heavy blanket | Placebo comparator | Device: Deep propioceptive stimulationPatients will start with non-heavy blanket during 15 days |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with PWS genetically confirmed at least 16y old willing to participate and being able to be still in the MRI.
Key exclusion criteria (8 listed)
- Age < 16 years old
- Presence of uncontrolled Obstructive Sleep Apnea (Residual AHI ≥ 30).
- Narcolepsy or other sleep disorders with daily somnolence
- Intolerance to the heavy blanket in spite of previous adaptation sessions
- Active psychopathological disorder that may interfere with sleep
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 |
|---|---|---|
| Deep propioceptive stimulationParticipants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket | Device | Heavy blanket, Non-heavy blanket |
Primary outcome
Changes in number of awakenings
Time frame: 14 nights
measured by actigraphy
Change in duration of awakenings
Time frame: 14 nights
minutes measured by actigraphy
4 secondary outcomes
Number of tantrums
Time frame: 15 days
number of skin injuries
Time frame: 15 days
Interest for food
Time frame: 15 days
Brain connectivity
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- 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. This study is not recruiting at the moment.
Assumpta Caixas, MD, PhD principal investigator
Corporacio Sanitaria Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep propioceptive stimulation in people with Sleep Disorder and Hyperphagia, run by Corporacion Parc Tauli at 1 site in Spain.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 25 Mar 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in number of awakenings (time frame: 14 nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2025.