Nasal Dryness Associated With Low-Flow Oxygen TherapyNCT07822451
Topical Nasal Moisturization for Oxygen-Related Nasal Dryness During Low-Flow Oxygen Therapy
A study testing Conventional Low-Flow Oxygen Therapy, 0.9% Isotonic Saline Nasal Drops and Hyaluronic Acid-Based Nasal Spray in people with Nasal Dryness Associated With Low-Flow Oxygen Therapy, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Conventional low-flow oxygen therapy delivered through a nasal cannula can cause nasal dryness and discomfort. This study evaluated whether topical nasal moisturization with 0.9% isotonic saline nasal drops or a hyaluronic acid-based nasal spray could reduce nasal dryness in adults receiving low-flow oxygen therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Dryness Associated With Low-Flow Oxygen Therapy
- What is being tested?
- Conventional Low-Flow Oxygen Therapy, 0.9% Isotonic Saline Nasal Drops and Hyaluronic Acid-Based Nasal Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2026to 30 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Admission to the coronary intensive care unit
- Receiving low-flow oxygen therapy via a standard nasal cannula
- Expected to require oxygen therapy for at least 12 hours
Who cannot join
- Severe nasal septal deviation
- Nasal polyps
- Recent nasal surgery or trauma
- Acute upper respiratory tract infection
- Allergic rhinitis
- Known hypersensitivity to isotonic saline or hyaluronic acid preparations
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Istanbul, 34674
About this study
Official title: Topical Nasal Moisturization for Oxygen-Induced Nasal Dryness During Conventional Low-Flow Oxygen Therapy: A Randomized Controlled Trial
Conventional low-flow oxygen therapy delivered through a nasal cannula can cause nasal dryness and discomfort. This study evaluated whether topical nasal moisturization with 0.9% isotonic saline nasal drops or a hyaluronic acid-based nasal spray could reduce nasal dryness in adults receiving low-flow oxygen therapy.
In this prospective, randomized, three-arm clinical trial, 150 adults receiving conventional low-flow nasal oxygen therapy in a coronary intensive care unit were assigned to one of three groups: low-flow oxygen alone, low-flow oxygen plus 0.9% isotonic saline nasal drops, or low-flow oxygen plus a hyaluronic acid-based nasal spray. All participants received low-flow oxygen alone during the first 4 hours. After the 4-hour assessment, the assigned topical nasal interventions were started and continued until the 12-hour assessment.
The primary outcome was patient-reported nasal dryness. Other assessments included patient comfort, nasal pain, clinician-assessed nasal mucosal dryness, nasal moisture measured using the intranasal Schirmer test, and epistaxis. Outcomes were assessed at 4 and 12 hours.
- Being tested
- Conventional Low-Flow Oxygen Therapy, 0.9% Isotonic Saline Nasal Drops, Hyaluronic Acid-Based Nasal Spray
- Keywords
- Low-flow oxygen therapy, Nasal dryness, Nasal moisturization, Isotonic saline, Hyaluronic acid, Intranasal Schirmer test, Patient comfort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Low-Flow Oxygen TherapyOther
Conventional low-flow oxygen therapy was administered via a standard nasal cannula according to the treating physician's clinical judgment and routine coronary intensive care practice.
0.9% Isotonic Saline Nasal DropsDrug
Participants received topical nasal moisturization with 0.9% isotonic saline nasal drops in addition to conventional low-flow oxygen therapy. The nasal drops were administered after the 4-hour pre-intervention assessment and repeated at 7 and 10 hours. Final outcome assessment was performed at 12 hours.
Hyaluronic Acid-Based Nasal SprayDrug
Participants received topical nasal moisturization with a hyaluronic acid-based nasal spray (Hylonem®) containing sodium hyaluronate, sodium chloride, grapefruit seed extract, and purified water, in addition to conventional low-flow oxygen therapy. The nasal spray was administered after the 4-hour pre-intervention assessment. Final outcome assessment was performed at 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Low-Flow Oxygen Alone | Active comparator | Participants received conventional low-flow oxygen therapy via nasal cannula without topical nasal moisturization. Receives: Other: Conventional Low-Flow Oxygen Therapy |
| Low-Flow Oxygen Plus Isotonic Saline | Experimental | Participants received conventional low-flow oxygen therapy plus topical nasal moisturization with 0.9% isotonic saline nasal drops. Receives: Other: Conventional Low-Flow Oxygen Therapy; Drug: 0.9% Isotonic Saline Nasal Drops |
| Low-Flow Oxygen Plus Hyaluronic Acid | Experimental | Participants received conventional low-flow oxygen therapy plus topical nasal moisturization with a hyaluronic acid-based nasal spray. Receives: Other: Conventional Low-Flow Oxygen Therapy; Drug: Hyaluronic Acid-Based Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Nasal Dryness
Patient-reported nasal dryness was assessed using a 10-cm visual analog scale (VAS), where 0 indicates no nasal dryness and 10 indicates the worst imaginable nasal dryness. Nasal dryness was assessed at 4 hours, before initiation of the assigned topical nasal intervention, and again at 12 hours.
Measured: At 4 hours (pre-intervention baseline) and 12 hours
Secondary outcomes (5)
Patient Comfort
Patient comfort was assessed using a 10-cm visual analog scale (VAS), where 0 indicates the worst possible comfort and 10 indicates the best possible comfort.
Measured: At 4 hours (pre-intervention baseline) and 12 hours
Patient-Reported Nasal Pain
Patient-reported nasal pain was assessed using a 10-cm visual analog scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measured: At 4 hours (pre-intervention baseline) and 12 hours
Clinician-Assessed Nasal Mucosal Dryness
Nasal mucosal dryness was assessed by a clinician using a standardized four-point ordinal scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Measured: At 4 hours (pre-intervention baseline) and 12 hours
Intranasal Schirmer Test
Nasal surface moisture was objectively assessed using the intranasal Schirmer test. Schirmer strips were placed intranasally, and the length of strip wetting was recorded in millimeters (mm), with higher values indicating greater nasal surface moisture.
Measured: At 4 hours (pre-intervention baseline) and 12 hours
Epistaxis
Epistaxis was assessed as the presence or absence of nasal bleeding at each assessment.
Measured: At 4 hours (pre-intervention baseline) and 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start29 Jul 2026
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Dryness Associated With Low-Flow Oxygen TherapyStudies 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
- Model description
- Participants were randomized in a 1:1:1 ratio to three parallel study groups.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Kinal, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822451
- Sponsor's protocol ID
- 1101
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in the publication may be shared upon reasonable request to the corresponding author, subject to applicable ethical and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Nasal Moisturization for Oxygen-Induced Nasal Dryness During Conventional Low-Flow Oxygen Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07822451
- Acronym / sponsor ID
- 1101
- Keywords
- Low-flow oxygen therapy, Nasal dryness, Nasal moisturization, Isotonic saline, Hyaluronic acid, Intranasal Schirmer test, Patient comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 16 Sep 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.
Conventional low-flow oxygen therapy delivered through a nasal cannula can cause nasal dryness and discomfort. This study evaluated whether topical nasal moisturization with 0.9% isotonic saline nasal drops or a hyaluronic acid-based nasal spray could reduce nasal dryness in adults receiving low-flow oxygen therapy.
In this prospective, randomized, three-arm clinical trial, 150 adults receiving conventional low-flow nasal oxygen therapy in a coronary intensive care unit were assigned to one of three groups: low-flow oxygen alone, low-flow oxygen plus 0.9% isotonic saline nasal drops, or low-flow oxygen plus a hyaluronic acid-based nasal spray. All participants received low-flow oxygen alone during the first 4 hours. After the 4-hour assessment, the assigned topical nasal interventions were started and continued until the 12-hour assessment.
The primary outcome was patient-reported nasal dryness. Other assessments included patient comfort, nasal pain, clinician-assessed nasal mucosal dryness, nasal moisture measured using the intranasal Schirmer test, and epistaxis. Outcomes were assessed at 4 and 12 hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were randomized in a 1:1:1 ratio to three parallel study groups.
| Arm | Type | Receives |
|---|---|---|
| Low-Flow Oxygen Alone | Active comparator | Other: Conventional Low-Flow Oxygen TherapyParticipants received conventional low-flow oxygen therapy via nasal cannula without topical nasal moisturization. |
| Low-Flow Oxygen Plus Isotonic Saline | Experimental | Other: Conventional Low-Flow Oxygen Therapy, Drug: 0.9% Isotonic Saline Nasal DropsParticipants received conventional low-flow oxygen therapy plus topical nasal moisturization with 0.9% isotonic saline nasal drops. |
| Low-Flow Oxygen Plus Hyaluronic Acid | Experimental | Other: Conventional Low-Flow Oxygen Therapy, Drug: Hyaluronic Acid-Based Nasal SprayParticipants received conventional low-flow oxygen therapy plus topical nasal moisturization with a hyaluronic acid-based nasal spray. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Admission to the coronary intensive care unit
- Receiving low-flow oxygen therapy via a standard nasal cannula
- Expected to require oxygen therapy for at least 12 hours
Key exclusion criteria (6 listed)
- Severe nasal septal deviation
- Nasal polyps
- Recent nasal surgery or trauma
- Acute upper respiratory tract infection
- Allergic rhinitis
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 |
|---|---|---|
| Conventional Low-Flow Oxygen TherapyConventional low-flow oxygen therapy was administered via a standard nasal cannula according to the treating physician's clinical judgment and routine coronary intensive care practice. | Other | Low-Flow Oxygen Alone, Low-Flow Oxygen Plus Hyaluronic Acid, Low-Flow Oxygen Plus Isotonic Saline |
| 0.9% Isotonic Saline Nasal DropsParticipants received topical nasal moisturization with 0.9% isotonic saline nasal drops in addition to conventional low-flow oxygen therapy. The nasal drops were administered after the 4-hour pre-intervention assessment and repeated at 7 and 10 hours. Final outcome assessment was performed at 12 hours. | Drug | Low-Flow Oxygen Plus Isotonic Saline |
| Hyaluronic Acid-Based Nasal SprayParticipants received topical nasal moisturization with a hyaluronic acid-based nasal spray (Hylonem®) containing sodium hyaluronate, sodium chloride, grapefruit seed extract, and purified water, in addition to conventional low-flow oxygen therapy. The nasal spray was administered after the 4-hour pre-intervention assessment. Final outcome assessment was performed at 12 hours. | Drug | Low-Flow Oxygen Plus Hyaluronic Acid |
Primary outcome
Patient-Reported Nasal Dryness
Time frame: At 4 hours (pre-intervention baseline) and 12 hours
Patient-reported nasal dryness was assessed using a 10-cm visual analog scale (VAS), where 0 indicates no nasal dryness and 10 indicates the worst imaginable nasal dryness. Nasal dryness was assessed at 4 hours, before initiation of the assigned topical nasal intervention, and again at 12 hours.
5 secondary outcomes
Patient Comfort
Time frame: At 4 hours (pre-intervention baseline) and 12 hours
Patient-Reported Nasal Pain
Time frame: At 4 hours (pre-intervention baseline) and 12 hours
Clinician-Assessed Nasal Mucosal Dryness
Time frame: At 4 hours (pre-intervention baseline) and 12 hours
Intranasal Schirmer Test
Time frame: At 4 hours (pre-intervention baseline) and 12 hours
Epistaxis
Time frame: At 4 hours (pre-intervention baseline) and 12 hours
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 16 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in the publication may be shared upon reasonable request to the corresponding author, subject to applicable ethical and institutional requirements.
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 Conventional Low-Flow Oxygen Therapy, 0.9% Isotonic Saline Nasal Drops and Hyaluronic Acid-Based Nasal Spray in people with Nasal Dryness Associated With Low-Flow Oxygen Therapy, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 16 Sep 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 Turkey (Türkiye). 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?
Patient-Reported Nasal Dryness (time frame: At 4 hours (pre-intervention baseline) and 12 hours). 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 16 Sep 2026.