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N/A N=156 Randomized Treatment

Continuous Positive Airway Pressure (PAP) Titration and Treatment Versus Auto-adjusting PAP Treatment for Sleep Apnea

Obstructive Sleep Apnea

Bottom Line

View on ClinicalTrials.gov: NCT00988351 ↗
Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Positive Airway Pressure Adherence (Nightly Use of Treatment) — 3.99; 4.45 hours — p== 0.27

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Continuous positive airway pressure (Device); Auto-adjusting positive airway pressure treatment (Device)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
North Florida Foundation for Research and Education
Primary completion
Dec 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Positive Airway Pressure Adherence (Nightly Use of Treatment)		 3.99; 4.45 = 0.27
SECONDARY
Change in Epworth Sleepiness Scale		 -3.7; -4.1 = 0.65
SECONDARY
Change in Functional Outcomes of Sleep Questionnaire		 2.2; 2.6 =0.33
SECONDARY
Residual Apnea-hypopnea Index		 4.9; 5.5 =0.49
SECONDARY
Treatment Pressure (Level of CPAP or 90th Percentile APAP)		 11.7; 10.8 =0.07

Summary

The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.

Eligibility Criteria

Inclusion Criteria

  • OSA, Apnea-hypopnea index > 5/hour

Exclusion Criteria

  • Prior CPAP
  • Uncontrolled Depression
  • Moderate to Severe chronic obstructive pulmonary disease (COPD)
  • Hypoventilation
  • Average estimated nightly total sleep time 40)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00988351). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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