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NCT Number: NCT05460598

The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine

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.

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Key information

Conditions

Itch Dyssomnias Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Pruritus Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mean itch intensity NRS > 5 in the past 3 days
  • Literacy and ability to read
  • Inpatient stay required for > 3 nights

Exclusion criteria

  • 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
  • Core body temperature >38°C
  • Use of other bedding > 8 hours or 2nd time request
  • Use of an occlusive therapy

Treatment and study plan

beddings with cooling effects

Other

beddings with cooling effects (mattress topper and bed linen)

commonly used bedding

Other

commonly used bedding

Primary outcomes

  1. 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)

Secondary outcomes

  1. Scratching activity measured by actigraph (Actigraph qGT3X-BT) on the dominant wrist

    Time frame: Continuously recorded throughout 72 hours

    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.

  2. 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)

    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.

  3. Patient questionnaire (regarding lying comfort, cooling pleasantness)

    Time frame: One time assessment after the third night

    Patient questionnaire regarding lying comfort, cooling pleasantness (5-point Likert scales, items "Strongly disagree", "Disagree", "Neither agree nor disagree", "Agree" and "Strongly agree")

  4. Patient questionnaire regarding cooling intensity

    Time frame: One time assessment after the third night

    Patient questionnaire regarding cooling intensity (0-10/ no cooling- strongest-possible cooling).

  5. Staff questionnaire regarding time practicability

    Time frame: Assessment after staff shift (3 times, altogether 72 hours)

    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.

  6. Vital signs measured by Fitbit tracker

    Time frame: Continuously recorded throughout 72 hours

    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).

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

The Effect of Cooling With a Bed Topper and Linen on Itch in Clinical Routine - an Exploratory Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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