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ISRCTN
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ISRCTN61835374
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ClinicalTrials.gov identifier
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Public title
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A study of the influence of pheromones on superosmia
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0274181493
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Study hypothesis
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The aim of this study is to evaluate the whether pheromones can influence the occurrence of superosmia during an olfactory threshold test.
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Lay summary
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Ethics approval
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Added September 2008: UCLH Committee (UK), ref 06/Q0505/10, 04/08/06 (Ethics Approval), 18/05/07 (R&D Approval).
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Ear, Nose and Throat: Superosmia
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Participants - inclusion criteria
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Anyone who considers themselves to have a normal sense of smell.
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Participants - exclusion criteria
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People who are found to be hyposmic/anosmic (ie lacking in ability to detect odours at normal levels), people with sino-nasal disease, people unable to understand spoken English or who are mentally impaired.
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Anticipated start date
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11/08/2008
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Anticipated end date
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01/08/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Number of participants: 100 total. 50 from West Suffolk.
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Interventions
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The study will take place at the ENT departments of Leicester Royal Infirmary and the West Suffolk Hospital. One hundred subjects will be recruited from amongst hospital staff who consider themselves to have a 'normal' sense of smell and no active sino-nasal disease. The study will take the form of a single-blinded randomised controlled trial. Subjects selected will be invited to undergo a 15 minute smell test and examination of their nose. They will be tested with a computer-driven olfactometer which enables a quantitative threshold test to be performed for several odours: phenethyl alcohol (roses), eucalyptol (menthol), acetic acid (vinegar) and mercaptan (gas). These odours have been shown to represent distinct entities in an individual’s sense of smell (1) and the test format has been validated in our previous work (2). The test involves the patient being seated in front of the olfactometer and the process of the test is explained to them by the researcher. At the voice prompts from the computer attached to the olfactometer, they will be asked to deliver two puffs of air from the spout using the two buttons attached to the olfactometer’s valve. The puffs of air are paired, one being a blank, the other containing the odour and they will be asked to identify the odour repeatedly like this in a forced response format until they have defined a threshold.
Following this they will then be exposed to either a pheromone (delta4,16-androstadien-3-one for female subjects and 1,3,5,(10),16-estratetraen-3-ol for male subjects) or sterile water - 1cm3 of the solution will be placed on a mask and held in front of the subjects nose for 2 minutes. The substance applied to the mask will be determined by use of a closed envelope system. Subjects will be then retested for their olfactory thresholds using the technique described above. This whole process will take less than an hour and no further involvement will be required of the individual subjects.
1. Gaskin JA, Robinson A, Philpott CM, Goodenough PC, Murty GE. Are patients cross-sensitive to odours in parallel threshold tests Chemical Senses 2006
2. Philpott CM, Dhanji F, Wolstenholme CR, Goodenough PC, Clark A, Murty GE. Eucalyptol olfactory threshold testing with a computer driven olfactometer. Journal of Laryngology and Otology 2006
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Primary outcome measure(s)
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Olfactory thresholds
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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West Suffolk Hospitals NHS Trust (UK), NHS R&D Support Funding
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Trial website
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Publications
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Contact name
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Mr
Carl
Philpott
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Address
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St Paul's Sinus Centre
St Paul's Hospital
1081 Burrard Street
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City/town
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Vancouver, BC
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Zip/Postcode
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V6Z 1Y6
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Country
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Canada
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Tel
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+1 604 806 9926
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Fax
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+1 604 806 9690
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Email
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carl.philpott@btinternet.com
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Sponsor
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University Hospitals of Leicester NHS Trust (UK)
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Address
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University Hospitals of Leicester NHS Trust Headquarters
Level 3, Balmoral Building
Leicester Royal Infirmary
Infirmary Square,
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City/town
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Leicester
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Zip/Postcode
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LE1 5WW
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Country
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United Kingdom
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Sponsor website:
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http://www.uhl-tr.nhs.uk/
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Date applied
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28/09/2007
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Last edited
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04/11/2010
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Date ISRCTN assigned
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28/09/2007
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