N/A
Completed N=40
Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
Source: ClinicalTrials.gov NCT01742949 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Adherence — 4.7; 5.0 hours per night
Summary
This study aims to investigate the benefits of using first 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence |
4.7; 5.0 | — |
| SECONDARY Epworth Sleepiness Score |
6.2; 6.0 | — |
| SECONDARY Short Functional Outcomes of Sleep Questionnaire (FOSQ-10) |
32.1; 32 | — |
| SECONDARY Subjective Dry Nose |
3.1; 4.8 | — |
| SECONDARY Subjective Dry Mouth |
5.2; 6.7 | — |
| SECONDARY Subjective Sinusitis |
1.8; 2.5 | — |
| SECONDARY Preference |
26; 11; 3 | — |
Eligibility 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
- Patients receiving social security coverage (excluding MEAs)
- Fluent spoken and written French
Exclusion Criteria
- Severe heart disease
- Co-existing lung disease
- Co-existing sleep disorder
- Pregnant
- Refused participation
Data sourced from ClinicalTrials.gov (NCT01742949). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.