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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00681083 |
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Date of registration:
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19/05/2008 |
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Primary sponsor: |
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Public title:
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Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
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Scientific title:
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Titrations Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification |
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Date of first enrolment:
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April 2008 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00681083 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Kevin L Lewis, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sleep Disorder Centers Institute for Clinical Research |
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Key inclusion & exclusion criteria
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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 < 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sleep Apnea, Obstructive
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Intervention(s)
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Device: Heated breathing tube (CPAP with ThermoSmart)
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Device: Non heated breathing tube (CPAP with conventional humidification)
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Primary Outcome(s)
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Titration pressures after treatment nights
[Time Frame: End of titration night]
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Secondary Outcome(s)
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Sleep Quality based on objective measures of sleep architecture and EEG arousals
[Time Frame: End of titration night]
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Secondary ID(s)
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FPHC SDC 2008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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