Cognitive AgingOLFAC-TLNCT07122037
Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy
A study testing DosMedical Smell Training Set and Nasal Airflow Inducing Maneuver in people with Cognitive Aging and Hyposmia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
Trial summary
To assess the efficacy of two olfactory rehabilitation protocols (Nasal Airflow-Inducing Maneuver (NAIM) with or without ol-factory training) on olfactory function (sniffing stick test) and quality of life (questionnaire Self-MOQ and EORTC QLQ-H\&N35) in patients with total laryngectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Aging, Hyposmia, Total Laryngectomy
- What is being tested?
- DosMedical Smell Training Set and Nasal Airflow Inducing Maneuver
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Sep 2021to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman over 18 years of age, with no upper age limit
- Patient scheduled to total laryngectomy either for oncological purpose (treatment approved by local tumor board) or for functional purpose (se-vere chronic inhalation)
- Capacity to understand and voluntarily sign an informed consent form. Exclusion criteria
- Insufficient French language skills.
- Preexistent anosmia (Sniffin' Stick test score <16/48)
- Contraindications to MRI imaging (e.g., metallic foreign bodies, claustro-phobia…)
- Severe chronic rhinosinusitis with polyps (Davos score 3 or more)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy : a Randomized Controlled Study
To assess the efficacy of two olfactory rehabilitation protocols (Nasal Airflow-Inducing Maneuver (NAIM) with or without ol-factory training) on olfactory function (sniffing stick test) and quality of life (questionnaire Self-MOQ and EORTC QLQ-H\&N35) in patients with total laryngectomy.
- Conditions
- Cognitive Aging, Hyposmia, Total Laryngectomy
- Being tested
- DosMedical Smell Training Set, Nasal Airflow Inducing Maneuver
- Keywords
- Anosmia, Hyposmia, Total laryngectomy, Quality of life, Olfactory bulb volume, Sniffin&#39; Sticks Test, NAIM
- Medical subject headings
- Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DosMedical Smell Training SetDevice
Olfactory training with four different odorants (e.g., rose, eucalyptus, lemon, and cloves) for approximately 10 seconds each, twice a day, in the morning and in the evening
Nasal Airflow Inducing ManeuverBehavioural
Repeated generation of an "underpressure" in the oral cavity by simultaneously lowering the jaw, the floor of the mouth the tongue, the base of the tongue and soft palate with securely closed lips. This negative pressure created in the oral cavity generates an airflow through the nose.
| Study group | Role | What they receive |
|---|---|---|
| NAIM + OT | Experimental | Total laryngectomy patients receiving olfactory rehabilitation with NAIM maneuver and olfactory training Receives: Device: DosMedical Smell Training Set; Behavioral: Nasal Airflow Inducing Maneuver |
| NAIM | Active comparator | Total laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver Receives: Behavioral: Nasal Airflow Inducing Maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory function
Prospectively assess the effect on olfactory function of adding olfactory training to a Nasal Airflow-Inducing Maneuver (NAIM) rehabilitation protocol after total laryngectomy.
Olfactory function was measured with the Sniffin' Sticks Test battery before surgery and at 1, 3, 6, and 12 months after surgery. According to normative data, hyposmia was defined as TDI scores ranging from 16.25 to 30.5, while functional anosmia was classified as a TDI score of 16 or below.
Measured: From total laryngectomy to the end of olfactory rehabilitation at 1 year
Olfactory-related quality of life
Prospectively assess the effect on olfactory-related quality of life of adding olfactory training to a Nasal Airflow-Inducing Maneuver (NAIM) rehabilitation protocol after total laryngectomy.
Participants assessed their smell-related quality of life using the validated Self-reported Mini Olfactory Questionnaire (Self-MOQ) before surgery and at 1, 3, 6, and 12 months after surgery. Additionally, the EORTC QLQ-H\&N35 questionnaire was used, specifically its senses scale, with scoring conducted according to the EORTC scoring manual. A higher score indicated greater olfactory dysfunction in both questionnaires.
Measured: From total laryngectomy to the end of olfactory rehabilitation at 1 year
Secondary outcomes (1)
Olfactory bulb volume
Investigate the impact of olfactory rehabilitation on the olfactory bulb volume after laryngectomy.
Olfactory bulb volume was measured on brain magnetic resonance imaging focusing on the olfactory bulb conducted preoperatively and six months after total laryngectory using a 3 Tesla system. Olfactory bulb volumes were measured bilaterally using coronal T2-weighted images with 2 mm-thick slices and no gaps.
Measured: Pre-operatively and 6 months after total laryngectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start7 Sep 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive AgingStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Mont-Godinne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nève Jean-Gualbert, University Hospital of Mont-Godinne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122037
- Sponsor's protocol ID
- 52/2021
- Acronym
- OLFAC-TL
- Status last verified
- Aug 2025
- First submitted
- 24 Jul 2025
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical and Sensorial Training in the Olfactive Rehabilitation of Patients With Total Laryngectomy : a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07122037
- Acronym / sponsor ID
- OLFAC-TL / 52/2021
- Conditions
- Cognitive Aging, Hyposmia, Total Laryngectomy
- Keywords
- Anosmia, Hyposmia, Total laryngectomy, Quality of life, Olfactory bulb volume, Sniffin&#39; Sticks Test, NAIM
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Hospital of Mont-GodinneUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 14 Aug 2025 (actual)
- 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.
To assess the efficacy of two olfactory rehabilitation protocols (Nasal Airflow-Inducing Maneuver (NAIM) with or without ol-factory training) on olfactory function (sniffing stick test) and quality of life (questionnaire Self-MOQ and EORTC QLQ-H\&N35) in patients with total laryngectomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAIM + OT | Experimental | Device: DosMedical Smell Training Set, Behavioral: Nasal Airflow Inducing ManeuverTotal laryngectomy patients receiving olfactory rehabilitation with NAIM maneuver and olfactory training |
| NAIM | Active comparator | Behavioral: Nasal Airflow Inducing ManeuverTotal laryngectomy patients receiving olfactory rehabilitation only with the NAIM maneuver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Man or woman over 18 years of age, with no upper age limit
- Patient scheduled to total laryngectomy either for oncological purpose (treatment approved by local tumor board) or for functional purpose (se-vere chronic inhalation)
- Capacity to understand and voluntarily sign an informed consent form. Exclusion criteria
- Insufficient French language skills.
- Preexistent anosmia (Sniffin' Stick test score <16/48)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| DosMedical Smell Training SetOlfactory training with four different odorants (e.g., rose, eucalyptus, lemon, and cloves) for approximately 10 seconds each, twice a day, in the morning and in the evening | Device | NAIM + OT |
| Nasal Airflow Inducing ManeuverRepeated generation of an "underpressure" in the oral cavity by simultaneously lowering the jaw, the floor of the mouth the tongue, the base of the tongue and soft palate with securely closed lips. This negative pressure created in the oral cavity generates an airflow through the nose. | Behavioural | NAIM, NAIM + OT |
Primary outcome
Olfactory function
Time frame: From total laryngectomy to the end of olfactory rehabilitation at 1 year
Prospectively assess the effect on olfactory function of adding olfactory training to a Nasal Airflow-Inducing Maneuver (NAIM) rehabilitation protocol after total laryngectomy. Olfactory function was measured with the Sniffin' Sticks Test battery before surgery and at 1, 3, 6, and 12 months after surgery. According to normative data, hyposmia was defined as TDI scores ranging from 16.25 to 30.5, while functional anosmia was classified as a TDI score of 16 or below.
Olfactory-related quality of life
Time frame: From total laryngectomy to the end of olfactory rehabilitation at 1 year
Prospectively assess the effect on olfactory-related quality of life of adding olfactory training to a Nasal Airflow-Inducing Maneuver (NAIM) rehabilitation protocol after total laryngectomy. Participants assessed their smell-related quality of life using the validated Self-reported Mini Olfactory Questionnaire (Self-MOQ) before surgery and at 1, 3, 6, and 12 months after surgery. Additionally, the EORTC QLQ-H\&N35 questionnaire was used, specifically its senses scale, with scoring conducted according to the EORTC scoring manual. A higher score indicated greater olfactory dysfunction in both questionnaires.
1 secondary outcome
Olfactory bulb volume
Time frame: Pre-operatively and 6 months after total laryngectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DosMedical Smell Training Set and Nasal Airflow Inducing Maneuver in people with Cognitive Aging and Hyposmia, run by University Hospital of Mont-Godinne at 1 site in Belgium.
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 7 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
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?
Olfactory function (time frame: From total laryngectomy to the end of olfactory rehabilitation at 1 year). 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?
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 14 Aug 2025.