Chronic RhinitisCryotherapyNCT07917091
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
An observational study of Chronic Rhinitis, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
Adult patients presenting with rhinitis who have persistent rhinitis despite appropriate medical treatment will receive a session of cryotherapy for the nose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- Cryotherapy alone
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Oct 2025to 22 Dec 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Adult patients with chronic rhinitis leading to a watery nose
Who may be able to join
None listed.
Who cannot join
- Confirmed CRS
- Allergic Rhinitis
- Cryoglobulinemia
- paroxysmal cold hemoglobinuria
- cold urticarial Raynaud's disease
- open and/or infected wounds or other skin conditions at or near the target tissue
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Lister Hospital
Stevenage, SG1 4AB
Toral Odedra, BSC Hons, 07342066620, toral.odedra@nhs.net
Joanna Stephens
About this study
Official title: Cryotherapy to the Nose for Chronic Rhinitis: A Single Site, Pilot Study in Adults
Adult patients presenting with rhinitis who have persistent rhinitis despite appropriate medical treatment will receive a session of cryotherapy for the nose.
Read the detailed description
Historically, patients with chronic rhinitis (having symptoms such as frequent runny nose, congestion and or post- nasal drip) have had limited surgical treatment options such as a vidian neurectomy. Cryotherapy to the posterior nasal nerves is an emerging. minimally invasive treatment that can be administered under local anaesthetic in the outpatient setting. NICE has recommended that cryotherapy for chronic rhinitis is investigated further, particularly which subtypes of rhinitis and the duration of benefit. The investigators intend to assess the feasibility of the treatment in the setting of an NHS outpatients prior to potentially developing a randomised trial. Therefore there will be a small sample size of 5-10 patients. Patients who decide to take part may expect to have two additional visits to their standard care, these being: the treatment visit and a 6 week follow up in addition to a usual 3 month follow up. Patient Reported Outcome Measures will be taken at the additional visits as well as the usual visits. Investigator data such as duration of procedure and ease of administration will also be measured.
- Conditions
- Chronic Rhinitis
- Being tested
- Cryotherapy alone
- Keywords
- watery nasal discharge, cryotherapy, rhinorrhoea, runny nose
- Medical subject headings
- Rhinitis, Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryotherapy aloneDevice
Freezing treatment to the back of the nose, done in the clinic setting via the nasal cavity under local anaesthetic
| Study group | Role | What they receive |
|---|---|---|
| One treatment group only, patients with excessively runny nose | Patients who present with a runny nose which is resistant to treatment, the intervention is cryotherapy to the back of the nose. Receives: Device: Cryotherapy alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in watery nasal discharge (runny nose)
as described by the patient
Measured: 6 weeks and 3 months
Change in Sino-Nasal Outcome Test-22 (SNOT-22) Score
Change in patient-reported sinonasal symptoms and health-related quality of life, assessed using the SNOT-22 questionnaire. The total score ranges from 0 to 110, with higher scores indicating worse symptoms and quality of life.
Measured: 6 weeks and 3 months
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score
Change in patient-reported nasal obstruction symptoms, assessed using the NOSE questionnaire. The total score ranges from 0 to 100, with higher scores indicating worse nasal obstruction
Measured: 6 weeks and 3 months
Change in Rhinitis Quality of Life Questionnaire (RQLQ) Score
Change in patient-reported rhinitis-related quality of life, assessed using the Rhinitis Quality of Life Questionnaire. Specify the questionnaire version and scoring range, including whether higher scores indicate worse quality of life
Measured: 6 weeks and 3 months
Change in Endoscopic Visual Analogue Scale (VAS) Score
Change in nasal appearance assessed by the doctor using endoscopic examination and the study-defined Visual Analogue Scale. Specify the minimum and maximum score and whether higher scores indicate better or worse nasal appearance.
Measured: 6 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start14 Oct 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion22 Dec 2026 (estimated)
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 Chronic RhinitisStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Phillip Smith, Study director, East & North Herts NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917091
- Sponsor's protocol ID
- RD2024-76
- Other IDs
- 351948
- Acronym
- Cryotherapy
- Status last verified
- Nov 2026
- First submitted
- 1 Jun 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran NP, Vickery J, Blaiss MS. Management of rhinitis: allergic and non-allergic. Allergy Asthma Immunol Res. 2011 Jul;3(3):148-56. doi: 10.4168/aair.2011.3.3.148. Epub 2011 May 20.
PubMed 21738880
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy to the Nose for Chronic Rhinitis: A Single Site, Pilot Study in Adults
- ClinicalTrials.gov ID
- NCT07917091
- Acronym / sponsor ID
- Cryotherapy / RD2024-76
- Conditions
- Chronic Rhinitis
- Keywords
- watery nasal discharge, cryotherapy, rhinorrhoea, runny nose
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 22 Dec 2026 (estimated)
- First posted
- 4 Nov 2026 (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.
Adult patients presenting with rhinitis who have persistent rhinitis despite appropriate medical treatment will receive a session of cryotherapy for the nose.
Detailed description
Historically, patients with chronic rhinitis (having symptoms such as frequent runny nose, congestion and or post- nasal drip) have had limited surgical treatment options such as a vidian neurectomy. Cryotherapy to the posterior nasal nerves is an emerging. minimally invasive treatment that can be administered under local anaesthetic in the outpatient setting. NICE has recommended that cryotherapy for chronic rhinitis is investigated further, particularly which subtypes of rhinitis and the duration of benefit. The investigators intend to assess the feasibility of the treatment in the setting of an NHS outpatients prior to potentially developing a randomised trial. Therefore there will be a small sample size of 5-10 patients. Patients who decide to take part may expect to have two additional visits to their standard care, these being: the treatment visit and a 6 week follow up in addition to a usual 3 month follow up. Patient Reported Outcome Measures will be taken at the additional visits as well as the usual visits. Investigator data such as duration of procedure and ease of administration will also be measured.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One treatment group only, patients with excessively runny nose | – | Device: Cryotherapy alonePatients who present with a runny nose which is resistant to treatment, the intervention is cryotherapy to the back of the nose. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with chronic rhinitis leading to a watery nose
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Confirmed CRS
- Allergic Rhinitis
- Cryoglobulinemia
- paroxysmal cold hemoglobinuria
- cold urticarial Raynaud's disease
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 |
|---|---|---|
| Cryotherapy aloneFreezing treatment to the back of the nose, done in the clinic setting via the nasal cavity under local anaesthetic | Device | One treatment group only, patients with excessively runny nose |
Primary outcome
Change in watery nasal discharge (runny nose)
Time frame: 6 weeks and 3 months
as described by the patient
Change in Sino-Nasal Outcome Test-22 (SNOT-22) Score
Time frame: 6 weeks and 3 months
Change in patient-reported sinonasal symptoms and health-related quality of life, assessed using the SNOT-22 questionnaire. The total score ranges from 0 to 110, with higher scores indicating worse symptoms and quality of life.
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score
Time frame: 6 weeks and 3 months
Change in patient-reported nasal obstruction symptoms, assessed using the NOSE questionnaire. The total score ranges from 0 to 100, with higher scores indicating worse nasal obstruction
Change in Rhinitis Quality of Life Questionnaire (RQLQ) Score
Time frame: 6 weeks and 3 months
Change in patient-reported rhinitis-related quality of life, assessed using the Rhinitis Quality of Life Questionnaire. Specify the questionnaire version and scoring range, including whether higher scores indicate worse quality of life
Change in Endoscopic Visual Analogue Scale (VAS) Score
Time frame: 6 weeks and 3 months
Change in nasal appearance assessed by the doctor using endoscopic examination and the study-defined Visual Analogue Scale. Specify the minimum and maximum score and whether higher scores indicate better or worse nasal appearance.
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 4 Nov 2026.
- Background: PubMed 21738880Tran NP, Vickery J, Blaiss MS. Management of rhinitis: allergic and non-allergic. Allergy Asthma Immunol Res. 2011 Jul;3(3):148-56. doi: 10.4168/aair.2011.3.3.148. Epub 2011 May 20.
- Individual participant dataSharing planned: No
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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.
Phillip Smith study director
East & North Herts NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinitis, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
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 0 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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 United Kingdom. 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?
Contact Joanna Stephens, MBChB FRCS (ORL-HNS) (01438 288019 ext. 8019, jaonnastephens@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in watery nasal discharge (runny nose) (time frame: 6 weeks and 3 months). The study lists 5 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 NCT07917091, 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 4 Nov 2026.