| Source of record | UK Trials |
| ISRCTN | ISRCTN61835374 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0274181493 |
| Public title | A study of the influence of pheromones on superosmia |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Ear, Nose and Throat: Superosmia |
| Study hypothesis | The aim of this study is to evaluate the whether pheromones can influence the occurrence of superosmia during an olfactory threshold test. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Anyone who considers themselves to have a normal sense of smell. |
| Participants - exclusion criteria | 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. |
| Patient information material |
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| Anticipated start date | 01/06/2006 |
| Anticipated end date | 01/06/2007 |
| Status of trial | Completed |
| Target number of participants | Number of participants: 100 total. 50 from West Suffolk. |
| Interventions | 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 |
| Primary outcome measure(s) | Olfactory thresholds |
| Secondary outcome measure(s) | None |
| Sources of funding | West Suffolk Hospitals NHS Trust
NHS R&D Support Funding |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Mr Carl Philpott |
| Contact details | Hardwick Lane
Bury St Edmunds
United Kingdom
IP33 2QZ |
| Contact telephone | +44 07801 417350 |
| Contact fax | +44 |
| Contact email | carl.philpott@btinternet.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN61835374 |
| Date last extracted from ISRCTN register | 17/04/2008 |
