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Completed

NCT Number: NCT00915499

Complex Sleep Apnea Syndrome (CompSAS) Resolution Study

The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.

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Key information

Conditions

Complex Sleep Apnea Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

REM Medical, Phoenix, Arizona, United States

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About this study

Between 3 and 19% of patients with clinical and polysomnographic features of obstructive sleep apnea syndrome (OSA) develop a high-frequency of central apneas and/or disruptive Cheyne-Stokes respiratory syndrome after application of continuous positive airway pressure (CPAP), a pattern called the complex sleep apnea syndrome (CompSAS). The trial seeks to determine the efficacy of the ASV vs. CPAP modes for the treatment of CompSAS over time. Baseline clinical and laboratory data will be collected, patients will be randomized to one of the two treatments. Overall study participation is approximately 3 months.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of complex sleep apnea syndrome (CompSAS)
  • Naive to PAP therapy
  • Requires CPAP ≤15 cm H2O

Exclusion criteria

  • Requires supplemental oxygen or with a baseline SaO2 <90%
  • Requires CPAP > 15 cm H2O
  • Primary diagnosis of moderate to severe chronic obstructive pulmonary disease, neuromuscular disease, chronic hyperventilation, stroke, cognitive impairment, such that could impair ability to answer subjective questions (study questionnaires) or unstable heart failure
  • Any contraindication for nasal or oro-nasal positive airway pressure, such as claustrophobia, severe nasal obstruction, or impaired mental status

Treatment and study plan

VPAP Adapt SV

Device

Comparison of ASV and CPAP modes

Primary outcomes

  1. Apnea-hypopnea Index (AHI) Per Polysomnography (PSG) at the End of Treatment Period

    Time frame: 3 months

    AHI refers to the number of apneas and hypopneas that occurred per hour of sleep

Secondary outcomes

  1. Quality of Life Measured by the Sleep Apnea Quality of Life Index (SAQLI)

    Time frame: 3 months

    Likert scale measured from 0-7. The minimum important difference a change of 0.5 when a 7-item Likert scale is used. 0 represents the most negative response, 7 represents the most positive response.

Sponsors and collaborators

Lead sponsor

ResMed

Industry

Collaborators

  • Mayo Clinic

Registry information

Official study title

Is Adaptive Servo-Ventilation Therapeutically More Effective Than Continuous Positive Airway Pressure In Treating Complex Sleep Apnea Syndrome?

Acronym: CompSAS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 8, 2009
Registry last updated
Feb 28, 2013

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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