Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed Obstructive Sleep Apnea (OSA) Patients

Obstructive Sleep Apnea Clinical Trial

Official title:

Automated Graduated CPAP (AGPAP) for Improved Adherence in Newly Diagnosed OSA Patients: Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01450540
• Other study ID #: AR-1112-AGPAP-MS
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: April 2013

Study information

• Verified date: February 2021
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Although positive airway pressure (PAP) is a highly effective treatment for sleep apnea, adherence to therapy remains an obstacle. Automated Graduated CPAP (AGPAP), also know as EZ-start, is an extended duration ramp, where the patient receives pressure below their prescription during an acclimation phase. The algorithm gradually increases pressure to therapy level based on usage. The aim of this study was to determine the effectiveness of the AGPAP acclimation period and its impact on short term adherence.

Description:

Even though CPAP is highly effective in treating sleep apnea, adherence to CPAP therapy remains the largest single obstacle to the successful resolution of sleep-disordered breathing in OSA patients. It has been estimated that up to 50% of patients who have been prescribed CPAP for Obstructive Sleep Apnea (OSA) are not using the treatment one year later. A myriad of possible causes for low compliance rates have been proposed and examined in previous studies. These include race, gender, education level, income, bed-partner's sleep quality, mask discomfort, continuity of care, nasal irritation, discomfort due to elevated expiratory pressure, and level of daytime sleepiness.

Therefore, many investigators have proposed new methods and approaches to help deal with these problems. Interventions have ranged from people-centric approaches using intensive CPAP education and follow-up programs, to device modifications using features such as a ramp, C-FLEX®, BiLevel therapy, and heated humidification.

In this study. The aim of this study was to determine the effectiveness of the Automated Graduated CPAP (AGPAP), also know as EZ-start acclimation period, and its impact on short term adherence

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Newly diagnosed with OSA (last 12 weeks)

• Prescribed continuous positive airway pressure (CPAP) pressure = 10 cmH2O

• Willing and able to provide informed consent

• Able to follow instructions

Exclusion Criteria:

• Participation in another interventional research study within the last 30 days

• Major controlled or an uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, chronic obstructive pulmonary disease (COPD), respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report and reviewed by the study PI.)

• Prior PAP prescription, use, or any prior OSA treatment, excluding split-night or titration PAP exposure.

• Prescribed BiLevel therapy

• Presence of untreated, non-OSA related sleep disorders (e.g. moderate to severe restless legs (PLMAI = 20) or insomnia)

• History of an automobile accident or near accident in the last 12 months due to sleepiness.

• Severe oxygen desaturation on the PSG (Sa02 < 70% for 10% of the diagnostic PSG study).

• Surgery of the upper airway, nose, sinus, or middle ear within the past 90 days

• Regular use (>3 nights per week) of sleeping pills or stimulants.

• Currently working a night shift or rotating day/night shift.

• Unwillingness to try PAP at home.

• Presence of tracheostomy

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• REMstar Auto A-Flex
Standard CPAP
• modified REMstar Auto A-Flex with AGPAP
Modified device -Software upgrade to GP 12

Locations

Country	Name	City	State
United States	Sleep Disorders Center of Georgia	Atlanta	Georgia
United States	Delta Waves Sleep Disorder and Research Center	Colorado Springs	Colorado
United States	Clinilabs, Inc.	New York	New York
United States	Clayton Sleep Institute	Saint Louis	Missouri
United States	Sleep Therapy and Research Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP Adherence	Device usage (hours per night)	3 months
Secondary	Functional Outcome Sleep Quality (FOSQ)	Functional Outcomes Sleep Questionnaire (FOSQ) is a self-administered instrument designed to assess the impact of excessive sleepiness on daytime function and to quantify improvement after treatment. It contains 30 items divided into 5 subscales: Activity level, vigilance, intimacy and sexual relationships, general productivity, and social outcome. The patient rates the difficulty of performing a given activity on a 4-point scale (no difficulty to extreme difficulty) A mean score is calculated for each scale ranging from 0 (maximum functional impact) to 24 (no functional impact).	3 months
Secondary	Daytime Sleepiness as Measured by the Epworth Sleepiness Scale	Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher is the overall 'daytime sleepiness'.	3 months