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

NCT00681083 | Completed Results

• 1 other identifier: FPHC SDC 2008
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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).

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea; Humidification; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

• Titration Pressures After Treatment Nights

  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.

  End of titration night

Secondary Outcomes (1)

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

  End of titration night

Study Arms (2)

1

EXPERIMENTAL

Heated breathing tube

Device: Heated breathing tube (CPAP with ThermoSmart)

2

ACTIVE COMPARATOR

Non heated breathing tube

Device: Non heated breathing tube (CPAP with conventional humidification)

Interventions

Heated breathing tube (CPAP with ThermoSmart) DEVICE

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

Also known as: ThermoSmart

1

Non heated breathing tube (CPAP with conventional humidification) DEVICE

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

Also known as: Conventional humidification

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead
• Sleep Disorder Centers Institute for Clinical Research: collaborator

Study Sites (2)

Sleep Center of Tulsa - Midtown

Tulsa, Oklahoma, 74135, United States

Location

Sleep Center of Tulsa - South

Tulsa, Oklahoma, 74137, United States

Location

Related Links

• Fisher \& Paykel Healthcare

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Hansinie Laing
• Organization: Fisher & Paykel Healthcare

CPAP.TRIAL@fphcare.co.nz

+64 9 574 0123

Study Officials

• Kevin L Lewis, M.D.

  Sleep Disorder Centers Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: April 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: June 12, 2019
• Results First Posted: June 12, 2019

Record last verified: 2019-05

Locations

US (2)