Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
This study is not yet open for participant recruitment.
Verified December 2012 by Fisher and Paykel Healthcare
Sponsor:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT01742949
First received: December 3, 2012
Last updated: December 4, 2012
Last verified: December 2012
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Purpose
This study aims to investigate the benefits of using fiirst line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP adherence. In addition, to determine if it is possible to predict which patients benefit the most (i.e. be more adherent with therapy) from high levels of humidification delivered by ThermoSmart.
| Condition | Intervention |
|---|---|
|
Diagnosed With OSA and Eligible for CPAP Treatment Naïve to CPAP Therapy Initial Proscription of a Nasal Mask |
Device: Heated humidification (ThermoSmart) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Further study details as provided by Fisher and Paykel Healthcare:
Primary Outcome Measures:
- Adherence [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Adherence with treatment per night averaged over total time period measured via internal software on the CPAP device and reported using InfoSmart™ software. The report will include all the supporting information recorded within the CPAP device.
Secondary Outcome Measures:
- Acceptance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Acceptance / drop-out rate, leak, ESS score, self-reported nasal symptoms, and functional outcomes of sleep questionnaire score
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Thermosmart
Subjects receive heated humidification
|
Device: Heated humidification (ThermoSmart) |
|
Placebo Comparator: No humidification
SUbjects use dry CPAP / APAP
|
Device: Heated humidification (ThermoSmart) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Older than 18 years of age
- Diagnosed with OSA and eligible for CPAP treatment under local requirements (AHI>30 or if AHI is lower than 30, at least 10 micro arousals identified during diagnosis PSG).
- Naïve to CPAP therapy, i.e have not been prescribed, or used CPAP in the last 5 years
- Initial proscription of a nasal mask (patients will be prescribed their mask following recruitment into the study. As per routine practice, most patients will be given a nasal mask. Prescription of full face mask will be at the discretion of the investigator
- Patients receiving social security coverage (excluding MEAs)
Exclusion Criteria:
- Severe heart disease
- Co-existing lung disease
- Co-existing sleep disorder
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742949
Contacts
| Contact: Marie-Pia D'Dortho, MD | +33 1 40 25 80 80 | marie-pia.dortho@bch.aphp.fr |
Locations
| France | |
| Hôpital Bichat-Claude Bernard | Not yet recruiting |
| Paris, Paris Cedex, France, 75877 | |
| Contact: Marie-Pia d'Ortho, MD | |
| Principal Investigator: Marie-Pia d'Ortho, MD | |
| Sub-Investigator: Caroline Schaeffer | |
| Sub-Investigator: Maria Stoïca | |
| Hôpital Tenon | Not yet recruiting |
| Paris, France | |
| Contact: Carole Philippe, MD carole.philippe@tnn.aphp.fr | |
| Principal Investigator: Carole Philippe, MD | |
| Hôpital Henri Mondor | Not yet recruiting |
| Paris, France | |
| Contact: Xavier Drouot, MD | |
| Principal Investigator: Xavier Drouot, MD | |
| Hôpital Louis Mourier | Not yet recruiting |
| Paris, France | |
| Contact: Dominique Maillard 01 47 60 62 48 dominique.maillard@lmr.aphp.fr | |
| Principal Investigator: Dominique Maillard | |
| Sub-Investigator: Najet BOUACH | |
Sponsors and Collaborators
Fisher and Paykel Healthcare
More Information
No publications provided
| Responsible Party: | Fisher and Paykel Healthcare |
| ClinicalTrials.gov Identifier: | NCT01742949 History of Changes |
| Other Study ID Numbers: | FPH-TS2012 |
| Study First Received: | December 3, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | France: Committee for the Protection of Personnes |
ClinicalTrials.gov processed this record on June 18, 2013