Sleep and VicksRub
Research type
Research Study
Full title
A 2-arm, randomised, single - (investigator) blind, controlled, parallel design study in common cold sufferers experiencing cough and nasal congestion to assess the effects of Vicks® VapoRub® (VVR) on elements of sleep quality
IRAS ID
142165
Contact name
Aldona Greenwood
Contact email
Sponsor organisation
Proctor and Gamble
Eudract number
2013-004524-11
ISRCTN Number
not provided
Research summary
The symptoms of a common cold include cough and nasal congestion. These symptoms are recognised barriers to restful, restorative sleep, so their relief may improve elements of sleep quality. Vicks® VapoRub® (VVR), a therapeutic ointment available over the counter in UK and other countries, is commonly used to relive these cold symptoms. VVR is a petroleum-based ointment which is either applied topically to the chest, throat, and back or added to hot water and the vapours inhaled. When applied on the skin, the active ingredients in VVR are evaporated by body temperature and inhaled into the airways. Its primary therapeutic effects are the reduction in cough frequency and feeling of relief from nasal congestion. This aim of this study is to investigate the effects of Vicks® VapoRub® (VVR), available over the counter in UK and other countries, on sleep quality in common cold sufferers.
A 100 adults (18 to 65 years) with a common cold, experiencing cough and nasal congestion will be studied in randomized, single - (Investigator) blind, placebo controlled, 2-arm (VVR vs. petrolatum) trial. 50 will receive VVR and 50 will receive placebo (petrolatum) to be applied on two successive nights just before sleep. During this time sleep parameters will be assessed using subjective questionnaires (ie, Subjective Quality of Sleep Questionnaire [SQSQ], Karolinska Sleep Diary [KSD], and wrist activity monitor [Actiwatch 4 (CamNtech Ltd, Cambridge, UK)].
REC name
London - Brent Research Ethics Committee
REC reference
13/LO/1722
Date of REC Opinion
29 Nov 2013
REC opinion
Favourable Opinion