Recruiting

Sinus Irrigation

Sponsor:

Bridgeport Hospital

Code:

NCT01121445

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NeilMed nose and sinus irrigation

Study Details

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.

Conditions

Obstructive Sleep Apnea

Study ID

NCT01121445

Start date

May, 2010

Status verified date

May, 2010

Completion date

Mar, 2011

Anticipated

Primary completion date

Mar, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: CPAP with heated humidification

Standard of care

Interventions

NeilMed nose and sinus irrigation

Saline irrigation used daily plus CPAP with heated humidification for 4 weeks

Primary outcome measure

  • RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire) [ Time Frame: 4 weeks ]

Central Contacts and Locations

Locations

Bridgeport Hospital

Recruiting

Bridgeport, Connecticut, United States, 06610

Contacts

Jeff S Kwon, MD

203-384-4142jkw109@gmail.com

More Information

Sponsor

Bridgeport Hospital

Last update posted

May 12, 2010

Last verified

May, 2010

Keywords

  • Sleep apnea
  • CPAP
  • Saline irrigation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Bridgeport Hospital on 2010-05-12.