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NCT Number: NCT01517750

Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence

Despite the effectiveness of continuous positive airway pressure (CPAP) in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal. One of the only technological advancements shown to increase adherence is heated humidification, now considered part of conventional CPAP therapy in some countries. ThermoSmart™ is a unique technology developed by Fisher & Paykel Healthcare which utilises a heated breathing tube to deliver optimal humidity in all environments. ThermoSmart has been shown to be superior to conventional humidification in reducing side effects, condensation and titrated pressure as well as increasing total sleep time. However, improved humidity delivery has not lead to significantly increased adherence in unselected obstructive sleep apnea (OSA) patients.

A total of 80 patients diagnosed with OSA but naive to CPAP use will be randomized into a single blind, randomized, parallel-arm trial to determine whether the the use of heated humidification will impact therapy adherence.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helios - Klinik Ambrock

Hagen, Weg, 60, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with OSA
  • Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
  • Prescribed a nasal mask (as patients will be prescribed their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)

Exclusion criteria

  • Severe heart disease
  • Co-existing lung disease
  • Co-existing sleep disorders
  • Pregnant

Treatment and study plan

ICON Auto CPAP™ with Thermosmart heated tube

Device

ICON Auto CPAP™ with heated humidification and the use of a heated tube

ICON Auto CPAP™ without Thermosmart heated tube

Device

ICON Auto CPAP™ without heated humidification or the use of a heated tube.

Primary outcomes

  1. Therapy Adherence With Treatment Per Night Averaged Over Total Time Period Measured Via Internal Software on the Device and Reported on Using InfoSmart™ Software With and Without Heated Humidification.

    Time frame: 6 weeks after patient randomization

Secondary outcomes

  1. Epworth Sleepiness Score (ESS)

    Time frame: 6 weeks after patient randomization

    The ESS is a measure of daytime sleepiness and has a total of 24 points. A range from 0-9 is considered normal. A score of more than 9 is considered to have abnormal daytime sleepiness

  2. Functional Outcome of Sleep Questionnaire (FOSQ)

    Time frame: 6 weeks after patient randomization

    FOSQ is a measure of the impact of the disorder on multiple activities with everyday living and how the treatment can improve these activities. There are 30 questions and for each questions you have to pick from a subscale from 0-4; 0 = "I don't do this activity for other reasons", 1="Yes extremely", 2="Yes moderately", 3= "Yes a little", 4 = "No". Scores of each subscale will be summed up and scaled to a maximum achievable value of 20. The sum score was calculated. The value range is 0-100. A higher score means that the treatment has positively improved everyday activities.

  3. Nasopharyngeal Complaints

    Time frame: 6 weeks after patient randomization

    Nasopharyngeal complaints (NPC) were assessed by a questionnaire. Subjects were asked to evaluate their condition on a scale from 0 ("no complaints") to 5 ("very strong"). The following questions were asked within the questionnaire: Did you observe nasal congestion, nasal dryness, runny nose, dry mouth, and dry throat (0-5 each) during the last week. The maximal achievable sum score was 25.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Collaborators

  • Helios Klinik Ambrock

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 25, 2012
Registry last updated
Jun 24, 2015

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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