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The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Bridgeport Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121445
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
NeilMed Pharmaceuticals
Information provided by:
Bridgeport Hospital
  Purpose
Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.

Condition Intervention
Obstructive Sleep Apnea Device: NeilMed nose and sinus irrigation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bridgeport Hospital:

Primary Outcome Measures:
  • RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) [ Time Frame: 4 weeks ]
    A 28-item, self administered questionnaire measuring nasal symptoms and other domains, including activity limitations and eye symptoms. Subjects will be asked to rate their symptoms on a 7-point scale (0=no impairment, 6=severely impaired). Change in RQLQ with daily saline irrigation in CPAP users is the primary outcome of interest.


Secondary Outcome Measures:
  • Epworth Sleepiness Scale [ Time Frame: 4 weeks ]
    The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.

  • SF-36 [ Time Frame: 4 weeks ]
    The Medical Outcome Study 36-Item Short Form health survey (SF-36) is a 36-item questionnaire which measures 8 domains of health: physical functioning, physical problems, emotional problems, social functioning, mental health, energy/vitality, pain, and general perception of health status. This questionnaire has been used as a validated measure of change in the quality of life of OSA patients on CPAP therapy.

  • CPAP compliance [ Time Frame: 4 weeks ]
    CPAP card compliance data will be measured to determine if use of daily sinus rinse is associated with an increase in CPAP use. The % of days CPAP used over 4 weeks and the average number of hours of CPAP use per night are the outcomes of interest.


Estimated Enrollment: 30
Study Start Date: May 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: CPAP with heated humidification
Standard of care
Device: NeilMed nose and sinus irrigation
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Apnea/hypopnea index ≥ 10
  • A documented successful CPAP titration

Exclusion Criteria:

  • Conditions that in the judgment of the investigator would interfere with subject participation in the study
  • History of sinus or nasal surgery
  • History of psychiatric illness
  • Use of sleep aids, sedatives or narcotics
  • Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
  • Bilevel or other nocturnal ventilation other than CPAP
  • Use of supplemental oxygen
  • Pregnancy or lactating
  • Inability or unwillingness to provide informed consent
  • Inability to perform baseline measurements
  • Inability to be contacted by phone
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121445


Locations
United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Jeff S Kwon, MD    203-384-4142    jkw109@gmail.com   
Sponsors and Collaborators
Bridgeport Hospital
NeilMed Pharmaceuticals
Investigators
Principal Investigator: Jeff S Kwon, MD Bridgeport Hospital
  More Information

Responsible Party: Jeff Kwon, MD/Associate Director of Sleep Medicine, Bridgeport Hospital Department of Medicine
ClinicalTrials.gov Identifier: NCT01121445     History of Changes
Other Study ID Numbers: IRB #041001
First Submitted: May 6, 2010
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Bridgeport Hospital:
Sleep apnea
CPAP
Saline irrigation

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases