A study of the influence of pheromones on superosmia
| ISRCTN | ISRCTN61835374 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61835374 |
| Protocol serial number | N0274181493 |
| Sponsor | University Hospitals of Leicester NHS Trust (UK) |
| Funder | West Suffolk Hospitals NHS Trust (UK), NHS R&D Support Funding |
- Submission date
- 28/09/2007
- Registration date
- 28/09/2007
- Last edited
- 16/01/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Carl Philpott
Scientific
Scientific
St Paul's Sinus Centre
St Paul's Hospital
1081 Burrard Street
Vancouver, BC
V6Z 1Y6
Canada
| Phone | +1 604 806 9926 |
|---|---|
| carl.philpott@btinternet.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | The aim of this study is to evaluate the whether pheromones can influence the occurrence of superosmia during an olfactory threshold test. |
| Ethics approval(s) | Added September 2008: UCLH Committee (UK), ref 06/Q0505/10, 04/08/06 (Ethics Approval), 18/05/07 (R&D Approval). |
| Health condition(s) or problem(s) studied | Ear, Nose and Throat: Superosmia |
| Intervention | 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 individuals 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 olfactometers 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 Updated 16/01/2014: The study did not proceed due to a lack of funds and personnel. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | pheromones |
| Primary outcome measure(s) |
Olfactory thresholds |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2009 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 100 |
| Key inclusion criteria | Anyone who considers themselves to have a normal sense of smell. |
| Key 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. |
| Date of first enrolment | 11/08/2008 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- United Kingdom
- Canada
Study participating centre
St Paul's Sinus Centre
Vancouver, BC
V6Z 1Y6
Canada
V6Z 1Y6
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
