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Completed

NCT Number: NCT00850876

Heated Humidified Continuous Positive Airway Pressure and Nasal Physiology

Nasal continuous positive airway pressure can cause nasal side effects which can compromise compliance to therapy. Humidifiers can attenuate this effect. However, the mechanism by which humidified CPAP alleviates nasal symptoms has never been assessed objectively in OSA patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on nasal airway physiology with combined measurements of nasal resistance and level of inflammatory markers. The investigators' hypothesis is that the addition of heated humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation markers and thus, ameliorates nasal symptoms of OSAS patients.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Critical Care and Pulmonary Services, Evangelismos Hospital

Athens, 10675, Greece

About this study

Introduction-Rationale:

Nasal continuous positive airway pressure (CPAP) is considered to be the "gold standard" of obstructive sleep apnoea (OSA) treatment [1]. The most common side effects are nasal congestion, stuffiness or dryness and rhinorrhea which have been reported in up to 68% of patients responding to a questionnaire about nasal CPAP. In many of them, CPAP compliance is accordingly compromised.

The mechanisms by which CPAP provokes nasal symptoms have been thoroughly studied only in healthy volunteers and a rodent model. Indeed, Richards et al demonstrated that mouth leaks causing high unidirectional nasal airflow increased nasal airway resistance and this response could be largely prevented by heated humidification of the inspired air. Similarly, Togias et al showed an elevated release of inflammatory mediators (histamine, prostaglandin D2, kinins) in nasal wash fluids when compressed cold and dry air was delivered through the nose. This effect was also prevented when warm and moist air was delivered. More recently, Almendros et al provided evidence that CPAP use in rats triggered early nasal inflammation.

Of the variety of methods used to treat nasal symptoms during CPAP treatment, the most common is humidification of the inspired air. However, the mechanism Oby which humidified CPAP attenuates nasal symptoms has never been assessed objectively in OSA patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on nasal airway physiology with combined measurements of nasal resistance and level of inflammatory markers. Our hypothesis is that the addition of heated humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation markers and thus, ameliorates nasal symptoms of OSAS patients.

Study design:

BASELINE: 1. NASAL SYMPTOMS 2. NASAL RESISTANCE 3. NASAL WASH (IL-6, IL-8, TNF-a, IL-10)

3 weeks humidified CPAP --------------> 3 weeks non-humidified CPAP <--------------

AFTER TREATMENT: 1. NASAL SYMPTOMS 2. NASAL RESISTANCE 3. NASAL WASH (IL-6, IL-8, TNF-a, IL-10)

Methods:

  • Nasal symptoms will be assessed using a five point Nasal Score. Each of the five principal nasal symptoms of rhinorrhoea, post-nasal drip, sneezing, impaired sense of smell and nasal blockage will be binary coded as present/increased over baseline (1) or absent/not (0) and summed to yield a total Nasal Score between zero and five.
  • Nasal resistance will be assessed by active anterior and posterior rhinomanometry in both seated and supine (for 10 min) positions.
  • Nasal wash will be performed using a technique adapted by Hurst et al. Briefly, a 12-French Foley catheter (Bard, Crawley, UK), modified by removal of the tip distal to the balloon, was inserted into the nostril and inflated with sufficient air to form a comfortable seal (typically 7-10ml). With the patients head flexed 45o forward, 7ml of warmed 0.9% saline will be instilled through the catheter and washed in and out of the nasal cavity three times. A portion of the pooled wash from both nostrils will be centrifuged to yield a supernatant for analysis of inflammatory cytokines.

By this protocol, the following are expected: a) the reason for potential congestion and inflammatory response is cold and dry air passing through the nostrils (mechanical irritation cannot be the reason, as the pressure is equivalent in both sessions), and b) heated and humidified CPAP prevents (and not treats) nasal congestion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstructive sleep apnea syndrome defined as apnea/hypopnoea index greater than 20,
  • Initiation of continuous positive airway pressure, and
  • Symptomatic nasal obstruction.

Exclusion criteria

  • No medication known to influence nasal resistance (antihistamines, vasoconstrictors, vasodilators, topical or systemic steroids, and recreation drugs),
  • No smoking,
  • No upper or lower respiratory tract disease (e.g. upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy.

Sponsors and collaborators

Lead sponsor

University of Athens

Other

Registry information

Official study title

Randomized Cross-over Trials of the Effect of Heated Humidified CPAP Versus Non-humidified CPAP on Nasal Physiology

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 25, 2009
Registry last updated
Apr 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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