Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification

Completed · Not applicable

Conditions studied: Sleep Apnea, Obstructive

In brief

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).

Key facts

Study ID: NCT00681083
Run by: Fisher and Paykel Healthcare
People needed: 26
Starts: 2008-04-01
Expected to finish: 2008-07-01
Last updated by the study team: 2019-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 < 40%
Obesity Hypoventilation Syndrome
Cheyne Stokes respiration
> 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

Where it is running

Sleep Center of Tulsa - Midtown — Tulsa, Oklahoma, United States
Sleep Center of Tulsa - South — Tulsa, Oklahoma, United States

Full record on ClinicalTrials.gov

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