- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121445
The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
May 11, 2010 updated by: Bridgeport Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
Bridgeport, Connecticut, United States, 06610
- Recruiting
- Bridgeport Hospital
-
Contact:
- Jeff S Kwon, MD
- Phone Number: 203-384-4142
- Email: jkw109@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: CPAP with heated humidification
Standard of care
|
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeff S Kwon, MD, Bridgeport Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
March 1, 2011
Study Completion (Anticipated)
March 1, 2011
Study Registration Dates
First Submitted
May 6, 2010
First Submitted That Met QC Criteria
May 11, 2010
First Posted (Estimate)
May 12, 2010
Study Record Updates
Last Update Posted (Estimate)
May 12, 2010
Last Update Submitted That Met QC Criteria
May 11, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB #041001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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