ItchNCT05460598
The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine
A study testing beddings with cooling effects and commonly used bedding in people with Itch, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch. The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Itch
- What is being tested?
- beddings with cooling effects and commonly used bedding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Aug 2022to 28 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean itch intensity NRS > 5 in the past 3 days
- Literacy and ability to read
- Inpatient stay required for > 3 nights
Who cannot join
- Age < 18 years
- Illiteracy
- Cognitive impairment (exclusion in case of mild cognitive impairment according to the Montreal-Cognitive Assessment (MOCA))
- The duration of the hospitalisation is foreseen to be shorter than 3 days
- Para- and Tetraplegia
- Hemisensory syndrome
Show all 9Show fewer
- Core body temperature >38°C
- Use of other bedding > 8 hours or 2nd time request
- Use of an occlusive therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Dermatology, University Hospital Basel
Basel, 4031
About this study
Official title: The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study
This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch.
The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.
Read the detailed description
Itch is the most common skin-related symptom. Staying/sleeping in a bed with a cooling properties could have a positive effect on (nocturnal) itch intensity, sleep quality and daytime performance in consequence. A mattress topper and bed linen with cooling effects that are commercially available (https://www.oba.ch/cool_gel_topper) by the OBA AG (Basel), which is the supplier of beds and bedding items of the University Hospital Basel, has been used in clinical routine. This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch and to better rationalize the beddings 'use. No comparative data is available and the design is purely exploratory. The primary objective of this study is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.
- Conditions
- Itch
- Being tested
- beddings with cooling effects, commonly used bedding
- Keywords
- cooling beddings, sleep quality, scratching, itch reduction, itch; nocturnal
- Medical subject headings
- Pruritus, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beddings with cooling effectsOther
beddings with cooling effects (mattress topper and bed linen)
commonly used beddingOther
commonly used bedding
| Study group | Role | What they receive |
|---|---|---|
| interventional group: beddings with cooling effects | Active comparator | Cooling beddings: linen made of the Outlast Technology https://www.outlast.com/en/. This product is made of 100 % lyocell and utilizes phase change materials based on natural wax. When this phase change material melts, heat is extracted from the environment and stored in microcapsules called thermocules. When the body cools down, these thermocules harden again release the heat from the linen. This might help to balances the body temperature and prevent warmth-aggravated itch.
- The mattress is made of polyurethane foam and designed as a "cool gel" topper to be placed onto the standard hospital mattress. Heat is also absorbed and stored into this topper. This topper is covered with an Obatex cover. It protects the "cool gel" topper from moisture and organic liquids and is made of polyamide fabric. Receives: Other: beddings with cooling effects |
| control group: commonly used bedding | Placebo comparator | Not described Receives: Other: commonly used bedding |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in (nocturnal) itch
improvement in (nocturnal) itch as measured by the 0-10 Numeric rating Scale (NRS) (at least 2 NRS points per 24 hours to obtain a meaningful therapeutic benefit). (NRS, 0= no itch, 10= worst imaginable)
Measured: NRS ratings will be assessed every 6 hours (throughout 72 hours)
Secondary outcomes (6)
Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist
Comparison of the actigraphy of the interventional versus control group.to record hand movements as a surrogate marker for scratching activity and to record sleep tracking functions.
Measured: Continuously recorded throughout 72 hours
Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality
Sleep quality assessment by RCSQ. It consists of six items addressing "Sleep depth", "Sleep latency", "Awakenings", "Returning to sleep", "Sleep quality" and "Noise", each of which is rated on a visual analogue scales ranging from 0-100 mm. A higher value of the average score represents better sleep.
Measured: Assessment after each night (3 times, altogether 72 hours)
Patient questionnaire (regarding lying comfort, cooling pleasantness)
Patient questionnaire regarding lying comfort, cooling pleasantness (5-point Likert scales, items "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree")
Measured: One time assessment after the third night
Patient questionnaire regarding cooling intensity
Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling).
Measured: One time assessment after the third night
Staff questionnaire regarding time practicability
Staff questionnaire regarding time practicability (putting on/of the linen, weight of topper, cleaning procedure of cooling beddings) (5-point Likert scales: "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree") after their shift.
Measured: Assessment after staff shift (3 times, altogether 72 hours)
Vital signs measured by Fitbit tracker
On the non-dominant wrist, patients will wear a tracker (Fitbit Charge 5, Fitbit LLC, USA) to capture vital signs (e.g. heart rate, respiratory rate and skin temperature).
Measured: Continuously recorded throughout 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start1 Aug 2022
- Primary completion28 May 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ItchStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, investigator-initiated, single-blinded, interventional, exploratory study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Mueller, PD Dr. med., Principal investigator, Department of Dermatology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05460598
- Sponsor's protocol ID
- 2022-00160; th21Mueller2
- Status last verified
- Aug 2024
- First submitted
- 4 Jul 2022
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study
- ClinicalTrials.gov ID
- NCT05460598
- Acronym / sponsor ID
- 2022-00160; th21Mueller2
- Conditions
- Itch
- Keywords
- cooling beddings, sleep quality, scratching, itch reduction, itch; nocturnal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 May 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 15 Jul 2022 (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.
This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch.
The primary objective is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.
Detailed description
Itch is the most common skin-related symptom. Staying/sleeping in a bed with a cooling properties could have a positive effect on (nocturnal) itch intensity, sleep quality and daytime performance in consequence. A mattress topper and bed linen with cooling effects that are commercially available (https://www.oba.ch/cool_gel_topper) by the OBA AG (Basel), which is the supplier of beds and bedding items of the University Hospital Basel, has been used in clinical routine. This single-blinded (only patients blinded) study is to assess the effect of cooling beddings on itch and to better rationalize the beddings 'use. No comparative data is available and the design is purely exploratory. The primary objective of this study is to test whether or not the use of the cooling beddings during 3 days can add at least 20% improvement in (nocturnal) itch as measured by the 0-10 NRS in comparison to a control group that does not use the cooling beddings.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-center, investigator-initiated, single-blinded, interventional, exploratory study.
| Arm | Type | Receives |
|---|---|---|
| interventional group: beddings with cooling effects | Active comparator | Other: beddings with cooling effectsCooling beddings: linen made of the Outlast Technology https://www.outlast.com/en/. This product is made of 100 % lyocell and utilizes phase change materials based on natural wax. When this phase change material melts, heat is extracted from the environment and stored in microcapsules called thermocules. When the body cools down, these thermocules harden again release the heat from the linen. This might help to balances the body temperature and prevent warmth-aggravated itch. - The mattress is made of polyurethane foam and designed as a "cool gel" topper to be placed onto the standard hospital mattress. Heat is also absorbed and stored into this topper. This topper is covered with an Obatex cover. It protects the "cool gel" topper from moisture and organic liquids and is made of polyamide fabric. |
| control group: commonly used bedding | Placebo comparator | Other: commonly used bedding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mean itch intensity NRS > 5 in the past 3 days
- Literacy and ability to read
- Inpatient stay required for > 3 nights
Key exclusion criteria (9 listed)
- Age < 18 years
- Illiteracy
- Cognitive impairment (exclusion in case of mild cognitive impairment according to the Montreal-Cognitive Assessment (MOCA))
- The duration of the hospitalisation is foreseen to be shorter than 3 days
- Para- and Tetraplegia
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 |
|---|---|---|
| beddings with cooling effectsbeddings with cooling effects (mattress topper and bed linen) | Other | interventional group: beddings with cooling effects |
| commonly used beddingcommonly used bedding | Other | control group: commonly used bedding |
Primary outcome
improvement in (nocturnal) itch
Time frame: NRS ratings will be assessed every 6 hours (throughout 72 hours)
improvement in (nocturnal) itch as measured by the 0-10 Numeric rating Scale (NRS) (at least 2 NRS points per 24 hours to obtain a meaningful therapeutic benefit). (NRS, 0= no itch, 10= worst imaginable)
6 secondary outcomes
Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist
Time frame: Continuously recorded throughout 72 hours
Richards-Campbell-Sleep Questionnaire (RCSQ) after each of the three nights addressing the sleep quality
Time frame: Assessment after each night (3 times, altogether 72 hours)
Patient questionnaire (regarding lying comfort, cooling pleasantness)
Time frame: One time assessment after the third night
Patient questionnaire regarding cooling intensity
Time frame: One time assessment after the third night
Staff questionnaire regarding time practicability
Time frame: Assessment after staff shift (3 times, altogether 72 hours)
Vital signs measured by Fitbit tracker
Time frame: Continuously recorded throughout 72 hours
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 15 Aug 2024.
Related trials for Itch
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Active, not recruiting
Identification of the Mechanism of Non-histaminergic Itch Inducing Epigenetic Changes
Itch
Recruiting
Investigate the Relationship Between Catastrophizing and the Perception of Itch Intensity in Healthy Individuals
Histamine, Cowhage
RecruitingPhase 3
Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis
Atopic Dermatitis, Atopic Dermatitis (AD)
Recruiting
Topographical Distribution of Itch and Pain Receptors
Pain, Itch
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.
Simon Mueller, PD Dr. med. principal investigator
Department of Dermatology, University Hospital Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beddings with cooling effects and commonly used bedding in people with Itch, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 9 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 15 Aug 2024. 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 Switzerland. 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?
improvement in (nocturnal) itch (time frame: NRS ratings will be assessed every 6 hours (throughout 72 hours)). 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 15 Aug 2024.