Compare Between Temperature-controlled and Nontemperature-controlled Radiofrequency Nose (CompareRF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01054521
First received: January 21, 2010
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

Both chronic rhinitis and obstructive sleep disordered breathing (OSDB) are very common and have a relatively strong association to each other. Treatment of rhinitis will have at least some benefits on OSDB patients. Currently, there are several alternative treatments for these patients including radiofrequency (RF) inferior turbinate reduction. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the effectiveness and safety of non-temperature-controlled RF (NTCRF) with the more popular TCRF. The investigators hypotheses that both have equal effectiveness and safety. However, the investigators believe that NTCRF have a lot less cost and faster to apply for OSDB patients in Thailand and other developing countries.


Condition Intervention
Snoring
Chronic Rhinitis
Procedure: Temperature-controlled RF
Device: ์NTCRF

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Study Between Temperature-controlled Radiofrequency and Nontemperature-controlled Inferior Turbinate Reduction in Patients With Snoring and Chronic Nasal Obstruction

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Visual Analog scale scores of nasal obstruction severity. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pain and safety [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TCRF
temperature-controlled RF The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.
Procedure: Temperature-controlled RF

The temperature-controlled RF was done under local anesthesia (0.5% xylocaine with adrenaline 1:200,000 injection at both inferior turbinates.) The RF probe will be inserted at inferior turbinate for 5 points both left and right nasal cavity (2 at anterior end, 2 at middle part and 1 at posterior end). We apply energy of 300 J, 85 C, and 15 W each point. After procedures the patients was observed at 1 hour before discharge without any packings.

For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.

Other Name: Temperature-controlled RF device is Gyrus ENT.
Active Comparator: NTCRF
non-temperature-controlled RF For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
Device: ์NTCRF
For nontemperature-controlled RF, the probe will be inserted at the same area with TCRF. We use 2.5 watt and 3 sec for each point but will stop immediately if the burning color or sound are detected. Otherwise was the same with TCRF.
Other Name: NONTemperature-controlled RF device is Select Sutter.

Detailed Description:

We will include around 100 patients, 50 for TCRF and 50 for NTCRF) and follow up for 1 year. We will compare both VAS, mucociliary test, ARM, RMM on all patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults with snoring and chronic nasal obstruction.
  • Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
  • Consent to the protocol.

Exclusion Criteria:

  • Chronic active sinusitis, severe DNS, nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
  • Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
  • Not complete the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01054521

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Wish Banhiran, MD    6624198040    wishbanh@hotmail.com   
Principal Investigator: wish banhiran, MD         
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Wish Banhiran, MD Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01054521     History of Changes
Other Study ID Numbers: wbanhiran
Study First Received: January 21, 2010
Last Updated: November 1, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
radiofrequency turbinate reduction
nasal obstruction
temperature-controlled radiofrequency
nontemperature-controlled radiofrequency
snoring in patients with chronic rhinitis.

Additional relevant MeSH terms:
Snoring
Rhinitis
Nasal Obstruction
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on April 23, 2014