Status:
COMPLETED
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Lead Sponsor:
Fisher and Paykel Healthcare
Collaborating Sponsors:
Sleep Disorder Centers Institute for Clinical Research
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wit...
Detailed Description
Debate is present concerning the optimal level of humidification for obstructive sleep apnea (OSA) patients who need continuous positive airway pressure (CPAP) therapy. Recent evidence has shown that ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00681083
Start Date
April 1 2008
End Date
July 1 2008
Last Update
June 12 2019
Active Locations (2)
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1
Sleep Center of Tulsa - Midtown
Tulsa, Oklahoma, United States, 74135
2
Sleep Center of Tulsa - South
Tulsa, Oklahoma, United States, 74137