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

This study has been completed.
Sponsor:
Collaborator:
Helios Klinik Ambrock
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT01517750
First received: January 18, 2012
Last updated: June 21, 2015
Last verified: June 2015

January 18, 2012
June 21, 2015
January 2012
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01517750 on ClinicalTrials.gov Archive Site
  • Epworth Sleepiness Score (ESS) [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]
    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
  • Functional Outcome of Sleep Questionnaire (FOSQ) [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]
    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.
  • Nasopharyngeal Complaints [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]
    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.
Prediction of the need of humidification use before therapy. [ Time Frame: 6 weeks after patient randomization ] [ Designated as safety issue: No ]

Prediction of the need of humidification use before therapy. Which patients are likely to profit from heated humidification with tube heating.

Acceptance rate, drop-out rate, leak, ESS score, Rhino FB score, self-reported nasal symptoms, and functional outcomes of sleep questionnaire score.

Not Provided
Not Provided
 
Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Sleep Apnea, Obstructive
  • Device: ICON Auto CPAP™ with Thermosmart heated tube
    ICON Auto CPAP™ with heated humidification and the use of a heated tube
  • Device: ICON Auto CPAP™ without Thermosmart heated tube
    ICON Auto CPAP™ without heated humidification or the use of a heated tube.
  • Experimental: APAP with humidification
    ICON Auto CPAP™ with Thermosmart heated tube
    Intervention: Device: ICON Auto CPAP™ with Thermosmart heated tube
  • Active Comparator: APAP without humidification
    ICON Auto CPAP™ without Thermosmart heated tube
    Intervention: Device: ICON Auto CPAP™ without Thermosmart heated tube
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01517750
FPH-OSA-TS-2012
No
Fisher and Paykel Healthcare
Fisher and Paykel Healthcare
Helios Klinik Ambrock
Principal Investigator: Georg Nilius, Dr. Helios Klinik Ambrock
Fisher and Paykel Healthcare
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP