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

NCT ID: NCT00681083

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2008-07-31

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 with ThermoSmart® technology (heated breathing tube technology) will have lower titrated pressures than those who are titrated using conventional humidification (non heated breathing tube).

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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Heated breathing tube

Group Type: EXPERIMENTAL

Heated breathing tube (CPAP with ThermoSmart)

Intervention Type: DEVICE

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

2

Non heated breathing tube

Group Type: ACTIVE_COMPARATOR

Non heated breathing tube (CPAP with conventional humidification)

Intervention Type: DEVICE

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

Interventions

Heated breathing tube (CPAP with ThermoSmart)

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

Intervention Type: DEVICE

Non heated breathing tube (CPAP with conventional humidification)

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

Intervention Type: DEVICE

Other Intervention Names

ThermoSmart; Conventional humidification

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sleep Disorder Centers Institute for Clinical Research

UNKNOWN

Sponsor Role: collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin L Lewis, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sleep Disorder Centers Institute for Clinical Research

Locations

Sleep Center of Tulsa - Midtown

Tulsa, Oklahoma, United States

Sleep Center of Tulsa - South

Tulsa, Oklahoma, United States

Countries

United States

Related Links

http://www.fphcare.com

Fisher \& Paykel Healthcare

Other Identifiers

FPHC SDC 2008

Identifier Type: -

Identifier Source: org_study_id