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Feasibility of an interval, inspiration-triggered nocturnal odorant application by a novel device: a patient-blinded, randomised crossover, pilot trial on mood and sleep quality of depressed female inpatients

  • Rhinology
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Abstract

It has been suggested that certain odorants positively affect mood, but this has not yet been scientifically tested in humans. The aim of the current study was to demonstrate the feasibility of a new odorant applicator and to assess the effects of nocturnal intermittent rose odorant application on mood, and quality of sleep and dreams in depressed female inpatients. We hypothesised that mood as primary outcome will improve. Twenty-seven normosmic, 18- to 49-year-old female, depressed inpatients were investigated in a randomised, placebo-controlled, crossover study. Exclusion criteria were rhinitis, hyp- or anosmia. During sleep, an interval-controlled, inspiration-triggered applicator added rose concentrate to the inspirated air. There were three consecutive nights of each odorant and placebo application and a wash-out phase. Patients completed standardised questionnaires on mood, dreams, and sleep quality. Four patients dropped out (n = 1: non-compliance in filling in the questionnaires, n = 3: intolerance of nasal tube). Otherwise, this novel odorant applicator was well tolerated. Application of the odorant showed no significant mood differences between rose and placebo, however, some subdomains of sleep quality and mood showed a positive trend towards improvement by rose application. The feasibility of this new device and of nasal tubes could be shown. Odorant application is well tolerated. It may have a positive influence on quality of mood and sleep in depressed patients. A longer application phase is planned to obtain convincing evidence for our hypothesis.

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Abbreviations

EMG:

Electromyogram

GES:

Recovery/recreation after sleep

SQ:

Sleep quality

PSYA:

Mental calmness before sleeping (Psychische Ausgeglichenheit vor dem Schlafenlegen)

PSYE:

Mental exhaustion before sleeping (Psychisches Erschöpftsein vor dem Schlafenlegen)

PSS:

Symptoms during sleep

PTSD:

Posttraumatic stress disorder

GS:

Good–bad mood

WM:

Alertness–fatigue

RU:

Rest–agitation

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Acknowledgments

The study was approved by the ethics committee of the University of Cologne Medical Centre (IRB Code 09-092). F.V. is supported by the German Federal Ministry of Research and Education (BMBF grant 01KN1106).The clinical testing and data acquisition was conducted in accordance with the, Good Clinical Practice (ICH-GCP)—Guidelines’ in principal and legal regulations. ICH International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

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Correspondence to Julia Vent.

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Vitinius, F., Hellmich, M., Matthies, A. et al. Feasibility of an interval, inspiration-triggered nocturnal odorant application by a novel device: a patient-blinded, randomised crossover, pilot trial on mood and sleep quality of depressed female inpatients. Eur Arch Otorhinolaryngol 271, 2443–2454 (2014). https://doi.org/10.1007/s00405-013-2873-6

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  • DOI: https://doi.org/10.1007/s00405-013-2873-6

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