Nasal Saline Irrigation for Pituitary Disease
(NOSE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Lori Wood
Must not be taking: Antibiotics
Disqualifiers: Sinusitis, Asthma, Pregnancy, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?This is a prospective, single-blinded, multicenter study evaluating the benefit of sinonasal irrigations following endoscopic pituitary surgery. The goal of this study is to create practice changing guidelines with objective data highlighting the importance of irrigations on postoperative outcomes for pituitary surgery.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on antibiotics for another condition, you may not be eligible to participate.
What data supports the effectiveness of the treatment Nasal Saline Irrigation for Pituitary Disease?
Research shows that nasal saline irrigation can help improve symptoms and quality of life in people with sinonasal conditions like chronic rhinosinusitis, suggesting it may also be beneficial for pituitary disease-related nasal issues.
12345Is nasal saline irrigation safe for humans?
Nasal saline irrigation is generally considered safe for humans, with no serious adverse events reported. Minor side effects like nasal discomfort can occur but are usually avoidable with proper technique and adjustments.
56789How is nasal saline irrigation unique for treating pituitary disease?
Nasal saline irrigation is unique for treating pituitary disease because it involves rinsing the nasal passages with a saline solution, which is different from typical drug treatments. This method is commonly used for sinonasal conditions and is considered safe, with no serious side effects, making it a novel approach for managing symptoms related to pituitary disease.
1461011Eligibility Criteria
This trial is for adults aged 18-85 who are undergoing endoscopic surgery to remove pituitary tumors. Participants must speak English and be able to understand specific nasal condition questionnaires. They should not have any conditions that make joining the study risky, as judged by the investigator.Inclusion Criteria
I am between 18 and 85 years old.
I have been diagnosed with a specific type of pituitary tumor or cyst.
Free of any physical, mental, or medical condition which, in the opinion of the investigator, makes study participation inadvisable
+5 more
Exclusion Criteria
Allergic rhinitis
I have asthma.
I am currently taking antibiotics for a condition other than cancer.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo endoscopic pituitary surgery followed by either standard postoperative nasal care with saline irrigations or no saline irrigations
12 weeks
Regular follow-ups at 1 week, 2 weeks, 4 weeks, 8 weeks, and 12 weeks
Follow-up
Participants are monitored for sinonasal quality of life and endoscopy findings post-treatment
12 weeks
Follow-up assessments at 1 week, 4 weeks, and 12 weeks
Participant Groups
The study is testing if nasal saline irrigation helps patients recover after endonasal pituitary surgery. It's a forward-looking, single-blinded test across multiple centers aiming to set new guidelines based on how these irrigations affect post-surgery recovery.
2Treatment groups
Active Control
Group I: Nasal saline irrigationActive Control1 Intervention
Patients randomized to standard postoperative nasal care with twice a day saline sinonasal irrigations
Group II: No InterventionActive Control1 Intervention
Patients randomized to not performing saline sinonasal irrigations.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cleveland ClinicCleveland, OH
Barrow Neurological Institute at St. Joseph's Hospital and Medical CenterPhoenix, AZ
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Who Is Running the Clinical Trial?
Lori WoodLead Sponsor
Nicole HillLead Sponsor
Barrow Brain and SpineCollaborator
References
Saline nasal irrigation: Its role as an adjunct treatment. [2018]To review clinical evidence on the efficacy of saline nasal irrigation for treatment of sinonasal conditions and to explore its potential benefits.
Saline irrigations following sinus surgery - a controlled, single blinded, randomized trial. [2021]Chronic rhinosinusitis (CRS) is a common health problem. If medical treatment fails, endonasal sinus surgery is a valuable treatment option. A thorough postsurgical treatment is needed including, among others, nasal saline irrigations (NSI). In this prospective, controlled, single blinded, randomized trial, we aimed to evaluate efficacy of nasal saline irrigations following endonasal sinus surgery in CRS-patients with nasal polyps.
Nasal saline for chronic sinonasal symptoms: a randomized controlled trial. [2015]To determine if isotonic sodium chloride (hereinafter "saline") nasal irrigations performed with large volume and delivered with low positive pressure are more effective than saline sprays at improving quality of life and decreasing medication use.
Clinical study and literature review of nasal irrigation. [2015]Nasal disease, including chronic rhinosinusitis and allergic rhinitis, is a significant source of morbidity. Nasal irrigation has been used as an adjunctive treatment of sinonasal disease. However, despite an abundance of anecdotal reports, there has been little statistical evidence to support its efficacy. The objective of this study was to determine the efficacy of the use of pulsatile hypertonic saline nasal irrigation in the treatment of sinonasal disease.
Nasal saline irrigation in pediatric rhinosinusitis: A systematic review. [2019]To determine the efficacy of nasal saline irrigation (NSI) in reducing symptoms and improving quality of life in pediatric patients with acute (ARS) or chronic (CRS) rhinosinusitis.
Saline nasal irrigation for upper respiratory conditions. [2021]Saline nasal irrigation is an adjunctive therapy for upper respiratory conditions that bathes the nasal cavity with spray or liquid saline. Nasal irrigation with liquid saline is used to manage symptoms associated with chronic rhinosinusitis. Less conclusive evidence supports the use of spray and liquid saline nasal irrigation to manage symptoms of mild to moderate allergic rhinitis and acute upper respiratory tract infections. Consensus guidelines recommend saline nasal irrigation as a treatment for a variety of other conditions, including rhinitis of pregnancy and acute rhinosinusitis. Saline nasal irrigation appears safe, with no reported serious adverse events. Minor adverse effects can be avoided with technique modification and salinity adjustment.
The effects of nasal lavage with betamethasone cream post-endoscopic sinus surgery: clinical trial. [2018]Steroid nasal irrigation for chronic rhinosinusitis patients following endoscopic sinus surgery reduces symptom recurrence. There are minimal safety data to recommend this treatment. This study evaluated the safety of betamethasone nasal irrigation by measuring its impact on endogenous cortisol levels.
[Application of nasal saline irrigation in nasal inflammatory diseases]. [2019]Nasal irrigation is a common topical treatment in rhinology. Saline irrigation(SI) is the most common and basic way of nasal irrigation. Mechanisms of action of SI contain physical clearance, regulation of nasal mucociliary function, enhancement of antimicrobial activity of nasal secretions and the effects of ions.Current solutions for SI differ in composition and physicochemical properties, specifically presence of additional ions, concentration of saline, pH values and temperature. Positive pressure should be an optimized method of SI. The side effects of SI include nasal discomfort, otalgia, and pooling of saline in sinuses with subsequent drainage. Furthermore, solutions are at the risk of contamination in SI.Despite the widely use of SI in the therapy of acute upper respiratory tract infections, allergic rhinitis, chronic rhinosinusitis and vasomotor rhinitis, evidence is still insufficient to support it. Researches in the use of SI on children is urgently needed.
Nasal saline irrigation: a clinical update. [2020]Nasal saline irrigation (NSI) plays an important role in the treatment of chronic rhinosinusitis (CRS). It is a beneficial low-risk treatment that serves an adjunctive function in the medical and surgical management of CRS. NSI is hypothesized to function by thinning mucous, improving mucociliary clearance, decreasing edema, and reducing antigen load in the nasal and sinus cavities. Although its use in CRS is nearly universal, significant variety exists with regard to delivery volume, delivery pressure, frequency of use, duration of use, composition, and hygiene recommendations. Evidence is limited regarding the most optimal methods of NSI delivery. In addition, use of NSI has recently come under increasing scrutiny due to potential associations with cases of primary amebic meningoencephalitis.
Efficacy of nasal irrigations and nebulizations for nasal symptom relief. [2015]To review current literature regarding the use and utility of nasal saline irrigation in nasal and sinus diseases.
New Ringer's lactate gel formulation on nasal comfort and humidification. [2022]The use of saline irrigation for nasal washes is a well established procedure in the treatment of sinonasal inflammation and infection. In addition to saline solutions, Ringer's lactate is also an efficient option for nasal washes and humidification.