Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea

Overview

That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.

Full Title of Study: “Effects of nCPAP With and Without Humidification on: Inspiratory Temperature, Humidity, Saccharine Transit Time, Nasal Lavage and in Vitro Mucus Properties in Patients With Obstructive Sleep Apnea”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 24, 2009

Interventions

  • Device: CPAP + ThermoSmart™ humidity
    • an absolute humidity (AH) of 28 mg/l +/- 2mg/l
  • Device: CPAP + Conventional humidity
    • an absolute humidity (AH) of 18 mg/l +/- 2 mg/l
  • Device: CPAP + No added humidity
    • ambient humidity

Arms, Groups and Cohorts

  • Active Comparator: CPAP + ThermoSmart™ humidity
  • Active Comparator: CPAP + Conventional humidity
  • Active Comparator: CPAP + No added humidity

Clinical Trial Outcome Measures

Primary Measures

  • mucociliary clearance.
    • Time Frame: pre and post cpap treatment with varying levels of humidity

Participating in This Clinical Trial

Inclusion Criteria

  • Moderate to severe obstructive sleep apnea – Apnea Hypopnea Index (AHI) > 15 – 75% of events during the diagnostic study must be obstructive Exclusion Criteria:

  • Currently using CPAP treatment OR have used it in the past 4 weeks – Intolerance of CPAP and/or CPAP mask in the past or during the titration night – Mouth breather (unable to breath through mouth for the study period) – < 18years old – Nasal CPAP intolerance determined in the PSG-CPAP titration study – Serious nasal issues – Acute upper airway disease – Smoker – COPD – Congestive heart failure – Neuromuscular disease – Stroke

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fisher and Paykel Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Geraldo Lorenzi, MD, Principal Investigator, Faculty of Medicine: Pulmonology: University of Sao Paulo Hospital

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