Clinical trial NCT01517750: Study to Predict the Need for Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure
ICON
ThermoSmart
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Helios Klinik Ambrock
First posted: 2012-01-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)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

Primary outcomes:
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.
timeFrame: 6 weeks after patient randomization
Secondary outcomes:
measure: Epworth Sleepiness Score (ESS)
timeFrame: 6 weeks after patient randomization
measure: Functional Outcome of Sleep Questionnaire (FOSQ)
timeFrame: 6 weeks after patient randomization
measure: Nasopharyngeal Complaints
timeFrame: 6 weeks after patient randomization
Other outcomes:
Locations:
city: Hagen
country: Germany
facility: Helios - Klinik Ambrock
state: Weg
Study officials:
affiliation: Helios Klinik Ambrock
name: Georg Nilius, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nilius G, Franke KJ, Domanski U, Schroeder M, Ruhle KH. Effect of APAP and heated humidification with a heated breathing tube on adherence, quality of life, and nasopharyngeal complaints. Sleep Breath. 2016 Mar;20(1):43-9. doi: 10.1007/s11325-015-1182-2. Epub 2015 May 10.