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

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. Identifier: NCT01121445
Recruitment Status : Unknown
Verified May 2010 by Bridgeport Hospital.
Recruitment status was:  Recruiting
First Posted : May 12, 2010
Last Update Posted : May 12, 2010
NeilMed Pharmaceuticals
Information provided by:
Bridgeport Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: NeilMed nose and sinus irrigation Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : May 2010
Estimated Primary Completion Date : March 2011
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.

  3. 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.

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

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

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 identifier (NCT number): NCT01121445

United States, Connecticut
Bridgeport Hospital Recruiting
Bridgeport, Connecticut, United States, 06610
Contact: Jeff S Kwon, MD    203-384-4142   
Sponsors and Collaborators
Bridgeport Hospital
NeilMed Pharmaceuticals
Principal Investigator: Jeff S Kwon, MD Bridgeport Hospital

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

Keywords provided by Bridgeport Hospital:
Sleep apnea
Saline irrigation

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