N/A
N=26
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00681083 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Titration Pressures After Treatment Nights — 9.8; 10.9 cmH20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Heated breathing tube (CPAP with ThermoSmart) (Device); Non heated breathing tube (CPAP with conventional humidification) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fisher and Paykel Healthcare
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Titration Pressures After Treatment Nights |
9.8; 10.9 | — |
| SECONDARY Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time |
.535; .058 | — |
Summary
Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification. It is hypothesised that patients with ThermoSmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).
Eligibility Criteria
Inclusion Criteria
- Male and Female patients over the age of 18
- Apnea Hypopnea Index (AHI) ≥15
- Patients must have at least 5 hours sleep time on each titration night
- Stable medications for 2 weeks prior to entry to the study and for study inclusion duration including sleep aids
Exclusion Criteria
- Receiving or requiring bi-level ventilation
- Use of a full face interface or chin strap
- Previous UPPP surgery or palatal reconstruction
- Recent angina symptoms within 2 weeks of entry
- CHF with EF 50% Central apneas recorded on diagnostic polysomnogram
- Supplemental oxygen use
- Use of narcotic pain medication
- Hypoxemia as determined by room air pulse oxymetry of less than 89% on room air at rest awake
- Inability to tolerate positive pressure therapy
- Split Night Evaluations
Data sourced from ClinicalTrials.gov (NCT00681083). 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.