Abstract
Common cold sufferers frequently report sleep disruption during the symptomatic period of infections. We examined the effects of treatment with a topical aromatic pharmaceutical ointment (Vicks VapoRub®), on associated sleep disturbances. The effects of Vicks VapoRub® versus placebo (petrolatum ointment) on subjective and objective measured sleep parameters were assessed in an exploratory study of 100 common cold patients, in a randomized, single blind, controlled, two-arm, parallel design study. The primary efficacy variable was subjective sleep quality measured with the SQSQ (Subjective Quality of Sleep Questionnaire). Additional measures included, ease of falling asleep and depth of sleep (measured with a post-sleep Visual Analog Scale), total sleep time, sleep onset latency, activity score, percentage of sleep, sleep efficiency (measured with actigraphy and SQSQ) and sleep quality index measured with a modified Karolinska Sleep Diary (KSD). The primary endpoint, “How was the quality of your sleep last night?” showed a statistically significant difference in change from baseline in favour of VapoRub treatment (p = 0.0392) versus placebo. Positive effects of VapoRub versus placebo were also observed for “How refreshed did you feel upon waking up?” (p = 0.0122) (SQSQ), “Did you get enough sleep?” (p = 0.0036) (KSD), “How was it to get up?” (p = 0.0120) (KSD) and “Do you feel well-rested?” (p = 0.0125) (KSD). No statistically significant changes from baseline versus placebo were detected in the Actiwatch endpoints. Vicks VapoRub®when applied before retiring to bed can reduce subjective sleep disturbances during a common cold. The results of this exploratory study support the belief among patients that the use of VapoRub improves subjective sleep quality during common cold which was associated with more refreshing sleep.