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

This study has been completed.
Sponsor:
Collaborator:
Sleep Disorder Centers Institute for Clinical Research
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00681083
First received: May 19, 2008
Last updated: July 10, 2011
Last verified: July 2011
  Purpose

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).


Condition Intervention
Sleep Apnea, Obstructive
Device: Heated breathing tube (CPAP with ThermoSmart)
Device: Non heated breathing tube (CPAP with conventional humidification)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Titrations Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification

Resource links provided by NLM:


Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • Titration pressures after treatment nights [ Time Frame: End of titration night ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep Quality based on objective measures of sleep architecture and EEG arousals [ Time Frame: End of titration night ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Heated breathing tube
Device: Heated breathing tube (CPAP with ThermoSmart)
CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube
Other Name: ThermoSmart
Active Comparator: 2
Non heated breathing tube
Device: Non heated breathing tube (CPAP with conventional humidification)
CPAP with conventional humidification - heated passover humidifier, no heated breathing tube
Other Name: Conventional humidification

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 using a heated breathing tube to increase the amount of humidification that can be delivered has decreased patient side effects, increased subjective sleep quality and decreased subjective symptom scores. Anecdotal evidence exists, in the form of clinical observation, when ThermoSmart® technology is utilized during CPAP titration, patients laboratory titrated pressure may in fact prove to be lower. The possibility exists, on a titration night, patients potentially may experience an adverse response to the positive airway pressure which manifests as increased airway resistance and inflammation necessitating higher CPAP pressures to overcome upper airway resistance and flow limitation. Therefore, we hypothesize the delivery of higher levels of humidity might reduce the nasal airway resistance during the titration night, reducing the overall positive airway pressure requirements. The goal is to investigate this phenomenon to find if a reduction in pressure is necessary and if so to what degree. Patients who are titrated on Continuous Positive Airway Pressure devices with ThermoSmart® technology will have lower titrated pressures than those who are titrated using conventional humidification.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 < 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681083

Locations
United States, Oklahoma
Sleep Center of Tulsa - Midtown
Tulsa, Oklahoma, United States, 74135
Sleep Center of Tulsa - South
Tulsa, Oklahoma, United States, 74137
Sponsors and Collaborators
Fisher and Paykel Healthcare
Sleep Disorder Centers Institute for Clinical Research
Investigators
Principal Investigator: Kevin L Lewis, M.D. Sleep Disorder Centers Institute for Clinical Research
  More Information

Additional Information:
No publications provided

Responsible Party: Emma Duckworth/Clinical Research Manager, Fisher & Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00681083     History of Changes
Other Study ID Numbers: FPHC SDC 2008
Study First Received: May 19, 2008
Last Updated: July 10, 2011
Health Authority: United States: Food and Drug Administration
New Zealand: Food Safety Authority

Keywords provided by Fisher and Paykel Healthcare:
Obstructive Sleep Apnea
Humidification
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on October 19, 2014