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NCT Number: NCT00681083

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heated breathing tube (CPAP with ThermoSmart)

Device

CPAP with ThermoSmart - heated passover humidifier, with heated breathing tube

Other names: ThermoSmart

Non heated breathing tube (CPAP with conventional humidification)

Device

CPAP with conventional humidification - heated passover humidifier, no heated breathing tube

Other names: Conventional humidification

Primary outcomes

  1. Titration Pressures After Treatment Nights

    Time frame: End of titration night

    Each night, the participant underwent a CPAP titration to determine their therapeutic pressure. During a titration, a sleep technician manually adjusts the participants pressure to determine which pressure is best for that individual in reducing their Apnea Hypopnea Index (AHI) which is the measure of Obstructive Sleep Apnea (OSA) severity. Titration pressures for each group were compared to see if there was any impact of having a heated breathing tube versus a non heated breathing tube on titration pressure.

Secondary outcomes

  1. Relationship Between the Intervention (Heated Breathing Tube vs Non Heated Breathing Tube) and Total Sleep Time

    Time frame: End of titration night

    A correlation table was computed to explore the relationship between the intervention (heated breathing tube vs no heated breathing tube) and total sleep time. This relationship was calculated for each arm and reported by a Correlation Coefficient (r score). The r score represents the strength and direction of a relationship between two variables. The value of r is always between -1 and +1. Therefore, an r score of -1 indicates a perfect negative relationship between the intervention and total sleep time. An r score of -.50 indicates a moderate negative relationship between the intervention and total sleep time. An r score of 0 indicates no relationship between the intervention and total sleep time. An r score of +.50 indicates a moderate positive relationship between the intervention and total sleep time. An r score of +1 indicates a perfect positive relationship between the intervention and total sleep time.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Collaborators

  • Sleep Disorder Centers Institute for Clinical Research

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 21, 2008
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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