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

Sleep Apnea, Obstructive Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01517750
• Other study ID #: FPH-OSA-TS-2012
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: June 21, 2015
• Start date: January 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesNew Zealand: Food Safety Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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their mask following recruitment into the study, any participants who are prescribed a full face mask will be withdrawn)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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Device:
• ICON Auto CPAP™ with Thermosmart heated tube
ICON Auto CPAP™ with heated humidification and the use of a heated tube
• ICON Auto CPAP™ without Thermosmart heated tube
ICON Auto CPAP™ without heated humidification or the use of a heated tube.

Locations

Country	Name	City	State
Germany	Helios - Klinik Ambrock	Hagen	Weg

Sponsors (2)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare	Helios Klinik Ambrock

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		6 weeks after patient randomization	No
Secondary	Epworth Sleepiness Score (ESS)	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	6 weeks after patient randomization	No
Secondary	Functional Outcome of Sleep Questionnaire (FOSQ)	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.	6 weeks after patient randomization	No
Secondary	Nasopharyngeal Complaints	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.	6 weeks after patient randomization	No

External Links

•   Sponsor Site