NCT01517750

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

June 24, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

11 months

First QC Date

January 18, 2012

Results QC Date

March 10, 2015

Last Update Submit

June 21, 2015

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep ApneaHumidificationContinuous Positive Airway PressureICONThermoSmart

Outcome Measures

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.

    6 weeks after patient randomization

Secondary Outcomes (3)

  • Epworth Sleepiness Score (ESS)

    6 weeks after patient randomization

  • Functional Outcome of Sleep Questionnaire (FOSQ)

    6 weeks after patient randomization

  • Nasopharyngeal Complaints

    6 weeks after patient randomization

Study Arms (2)

APAP with humidification

EXPERIMENTAL

ICON Auto CPAP™ with Thermosmart heated tube

Device: ICON Auto CPAP™ with Thermosmart heated tube

APAP without humidification

ACTIVE COMPARATOR

ICON Auto CPAP™ without Thermosmart heated tube

Device: ICON Auto CPAP™ without Thermosmart heated tube

Interventions

ICON Auto CPAP™ with Thermosmart heated tubeDEVICE

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

APAP with humidification
ICON Auto CPAP™ without Thermosmart heated tubeDEVICE

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

APAP without humidification

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios - Klinik Ambrock

Hagen, Weg, 60, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25957615DERIVED

Related Links

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Dr Georg Nilius
Organization
HELIOS-Klinik Ambrock
klinik-ambrock.pneumo@t-online.de
+492331-9742005

Study Officials

  • Georg Nilius, Dr.

    Helios Klinik Ambrock

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 25, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 24, 2015

Results First Posted

June 24, 2015

Record last verified: 2015-06

Locations

DE(1)