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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeilMed nose and sinus irrigation
Sponsored by
Bridgeport Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Sleep apnea, CPAP, Saline irrigation

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bridgeport HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

CPAP with heated humidification

Arm Description

Standard of care

Outcomes

Primary Outcome Measures

RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
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
The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.
SF-36
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
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.

Full Information

First Posted
May 6, 2010
Last Updated
May 11, 2010
Sponsor
Bridgeport Hospital
Collaborators
NeilMed Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01121445
Brief Title
The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2011 (Anticipated)
Study Completion Date
March 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Bridgeport Hospital
Collaborators
NeilMed Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Sleep apnea, CPAP, Saline irrigation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP with heated humidification
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Device
Intervention Name(s)
NeilMed nose and sinus irrigation
Intervention Description
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks
Primary Outcome Measure Information:
Title
RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale
Description
The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.
Time Frame
4 weeks
Title
SF-36
Description
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.
Time Frame
4 weeks
Title
CPAP compliance
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff S Kwon, MD
Organizational Affiliation
Bridgeport Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bridgeport Hospital
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff S Kwon, MD
Phone
203-384-4142
Email
jkw109@gmail.com

12. IPD Sharing Statement

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

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