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 because the information has not been verified recently.
Verified May 2010 by Bridgeport Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
NeilMed Pharmaceuticals
Information provided by:
Bridgeport Hospital
ClinicalTrials.gov Identifier:
NCT01121445
First received: May 6, 2010
Last updated: May 11, 2010
Last verified: May 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 6, 2010
Last Updated: May 11, 2010
Health Authority: United States: Institutional Review Board

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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014