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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01121445
• Other study ID #: IRB #041001
• Status: Recruiting
• Phase: N/A
• First received: May 6, 2010
• Last updated: May 11, 2010
• Start date: May 2010
• Est. completion date: March 2011

Study information

• Verified date: May 2010
• Source: Bridgeport Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• NeilMed nose and sinus irrigation
Saline irrigation used daily plus CPAP with heated humidification for 4 weeks

Locations

Country	Name	City	State
United States	Bridgeport Hospital	Bridgeport	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Bridgeport Hospital	NeilMed Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks	No
Secondary	Epworth Sleepiness Scale	The Epworth Sleepiness Scale is a self administered questionnaire that measures subjective daytime hypersomnia on a scale of 0 to 24.	4 weeks	No
Secondary	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.	4 weeks	No
Secondary	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.	4 weeks	No