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

Bridgeport Hospital

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Device: NeilMed nose and sinus irrigation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01121445

IRB #041001

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 1 patient group

CPAP with heated humidification

No Intervention group

Description:

Standard of care

Treatment:

Device: NeilMed nose and sinus irrigation