People With Normal Sense of SmellNCT02980718
Does Olfactory Training Improve Olfaction in a Population With Normal Sense of Smell?
A study testing intensive olfactory training and ordinary olfactory training in people with People With Normal Sense of Smell, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Awareness of the sense of smell in the western population has been low. Most people do not think about the consequences of absence of smell (anosmia). Reduction in sense of smell (hyposmia) can influence everyday life. In situations of stress anosmia can be life threatening for example when there is a fire. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- People With Normal Sense of Smell
- What is being tested?
- intensive olfactory training and ordinary olfactory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2016to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TDI score > 30.5 measured by Sniffin'Sticks
Who cannot join
- Not able to follow the olfactory training or follow-up (language, practical implementation, mental condition)
- Disease affecting olfaction (sinusitis, pronounced allergies, recent nasal surgery, Alzheimer's, Parkinson, MS, COPD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Olfactory Training Improve Olfaction in a Population With Normosmia and How is Their Self Assessment of Sense of Smell?
Awareness of the sense of smell in the western population has been low. Most people do not think about the consequences of absence of smell (anosmia). Reduction in sense of smell (hyposmia) can influence everyday life. In situations of stress anosmia can be life threatening for example when there is a fire. Cooks may lose their job. Not being able to enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of the nose and sinuses or head injuries. OD may be congenital, age related or associated with neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the first symptom of both Parkinson's and Alzheimer's disease several years before the mental changes occur.
Knowledge and focus on OD has until recently been low among most physicians and treatment options have often not been available. Different approaches to improve OD have been tried with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc gluconate and vitamin A. In recent years, olfactory training has been launched as a promising treatment option. Most studies with olfactory training are done with patients with OD. A recently published review describes 10 studies with olfactory training among 639 patients and concludes that daily stimulation with odorants (odor concentrate) over a limited period time is a promising treatment. The suggested duration of olfactory training varies from 3 to 14 months. Different intensities of olfactory training were compared in patients with post-viral OD. Olfaction was more improved by the high concentration of odorant than by the low concentration.
Read more
A small number of studies have shown that the olfactory nerve to some extent can be trained in persons with normal sense of smell, but we need more experience and structured studies to be able to conclude with greater certainty about the effect of olfactory training in this population.
This study examines whether intensive olfactory training improves the sense of smell more than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines self-evaluation of olfactory function.
Read the detailed description
Sub-study: Part of the participants (45/200) will be included in a pilot study which will be an analytical observational study to compare olfactory bulb volume measured on MRI three times during a year, while at the same time resting state fMRI will be measured before and after olfactory training. There is not sufficient data in the literature for power calculations and this sub-study is therefore a pilot study.
- Conditions
- People With Normal Sense of Smell
- Being tested
- intensive olfactory training, ordinary olfactory training
- Keywords
- Olfaction training, Smell
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive olfactory trainingBehavioural
ordinary olfactory trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| intensive olfactory training | Experimental | 90 participants will undergo intensive olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 4 minutes) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training. Receives: Behavioral: intensive olfactory training |
| ordinary olfactory training | Experimental | 90 participants will undergo ordinary olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 40 seconds) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training. Receives: Behavioral: ordinary olfactory training |
| controls | No intervention | 20 participants represent a control group with no olfactory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
olfaction assessed by TDI-score according to extended Sniffin'Sticks
Measured: 4 months (immediately after completion of the training period)
olfaction self-evaluated and reported in a questionnaire
Measured: 4 months (immediately after completion of the training period)
Secondary outcomes (2)
olfaction assessed byTDI-score according to extended Sniffin'Sticks
Measured: 1 year (6-7 months after completion of the training period)
olfaction self-evaluated and reported in a questionnaire
Measured: 1 year (6-7 months after completion of the training period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startDec 2016
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for People With Normal Sense of SmellStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ståle Nordgård, md prof, Study director, Norwegian University of Science and TechnologyMarit Fagerli, md, Study director, St Olavs Hospital, Klinikk for Øre Nese Hals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980718
- Sponsor's protocol ID
- 2016/837
- Status last verified
- May 2020
- First submitted
- 30 Nov 2016
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katotomichelakis M, Balatsouras D, Tripsianis G, Tsaroucha A, Homsioglou E, Danielides V. Normative values of olfactory function testing using the 'sniffin' sticks'. Laryngoscope. 2007 Jan;117(1):114-20. doi: 10.1097/01.mlg.0000246518.79894.7e.
PubMed 17202939
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Olfactory Training Improve Olfaction in a Population With Normosmia and How is Their Self Assessment of Sense of Smell?
- ClinicalTrials.gov ID
- NCT02980718
- Acronym / sponsor ID
- 2016/837
- Conditions
- People With Normal Sense of Smell
- Keywords
- Olfaction training, Smell
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Dec 2016 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Awareness of the sense of smell in the western population has been low. Most people do not think about the consequences of absence of smell (anosmia). Reduction in sense of smell (hyposmia) can influence everyday life. In situations of stress anosmia can be life threatening for example when there is a fire. Cooks may lose their job. Not being able to enjoy food and drink interferes with quality of life. The causes of olfactory dysfunction (OD) vary. Most often OD is associated with upper respiratory tract infections, disease of the nose and sinuses or head injuries. OD may be congenital, age related or associated with neurological disorders. Hyposmia occurs in up to 85% of cases of Parkinson's and may be the first symptom of both Parkinson's and Alzheimer's disease several years before the mental changes occur.
Knowledge and focus on OD has until recently been low among most physicians and treatment options have often not been available. Different approaches to improve OD have been tried with variable effect depending on the cause of OD. There are studies on corticosteroids, zinc gluconate and vitamin A. In recent years, olfactory training has been launched as a promising treatment option. Most studies with olfactory training are done with patients with OD. A recently published review describes 10 studies with olfactory training among 639 patients and concludes that daily stimulation with odorants (odor concentrate) over a limited period time is a promising treatment. The suggested duration of olfactory training varies from 3 to 14 months. Different intensities of olfactory training were compared in patients with post-viral OD. Olfaction was more improved by the high concentration of odorant than by the low concentration.
A small number of studies have shown that the olfactory nerve to some extent can be trained in persons with normal sense of smell, but we need more experience and structured studies to be able to conclude with greater certainty about the effect of olfactory training in this population.
This study examines whether intensive olfactory training improves the sense of smell more than ordinary olfactory training in subjects with normal olfaction (normosmia) and examines self-evaluation of olfactory function.
Detailed description
Sub-study: Part of the participants (45/200) will be included in a pilot study which will be an analytical observational study to compare olfactory bulb volume measured on MRI three times during a year, while at the same time resting state fMRI will be measured before and after olfactory training. There is not sufficient data in the literature for power calculations and this sub-study is therefore a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intensive olfactory training | Experimental | Behavioral: intensive olfactory training90 participants will undergo intensive olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 4 minutes) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training. |
| ordinary olfactory training | Experimental | Behavioral: ordinary olfactory training90 participants will undergo ordinary olfactory training. They will sniff on four selected odors (10 seconds on each odor bottle in a total of 40 seconds) every morning and evening for 3 months and they will be instructed in the principles of the logbook for olfactory training. |
| controls | No intervention | –20 participants represent a control group with no olfactory training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- TDI score > 30.5 measured by Sniffin'Sticks
Key exclusion criteria (2 listed)
- Not able to follow the olfactory training or follow-up (language, practical implementation, mental condition)
- Disease affecting olfaction (sinusitis, pronounced allergies, recent nasal surgery, Alzheimer's, Parkinson, MS, COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive olfactory training | Behavioural | intensive olfactory training |
| ordinary olfactory training | Behavioural | ordinary olfactory training |
Primary outcome
olfaction assessed by TDI-score according to extended Sniffin'Sticks
Time frame: 4 months (immediately after completion of the training period)
olfaction self-evaluated and reported in a questionnaire
Time frame: 4 months (immediately after completion of the training period)
2 secondary outcomes
olfaction assessed byTDI-score according to extended Sniffin'Sticks
Time frame: 1 year (6-7 months after completion of the training period)
olfaction self-evaluated and reported in a questionnaire
Time frame: 1 year (6-7 months after completion of the training period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Background: PubMed 17202939Katotomichelakis M, Balatsouras D, Tripsianis G, Tsaroucha A, Homsioglou E, Danielides V. Normative values of olfactory function testing using the 'sniffin' sticks'. Laryngoscope. 2007 Jan;117(1):114-20. doi: 10.1097/01.mlg.0000246518.79894.7e.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ståle Nordgård, md prof study director
Norwegian University of Science and Technology
Marit Fagerli, md study director
St Olavs Hospital, Klinikk for Øre Nese Hals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intensive olfactory training and ordinary olfactory training in people with People With Normal Sense of Smell, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
olfaction assessed by TDI-score according to extended Sniffin'Sticks (time frame: 4 months (immediately after completion of the training period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2020.