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N/A Completed N=21 Randomized Treatment

Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV

Periodic Breathing · Breathing-Related Sleep Disorder
Source: ClinicalTrials.gov NCT01405313 ↗
Enrolled (actual)
21
Serious AEs
2.4%
Results posted
Mar 2017
Primary outcomePrimary: Apnea/Hypopnea Index (AHI) — 3.9; 6.4 Events per hour — p=0.022

Summary

This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing. The study will determine if the modified ASV reacts appropriately to reduce apneas and hypopneas and provides suitable levels of positive airway pressure compared to conventional ASV.

Outcome Measures

OutcomeResultp-value
PRIMARY
Apnea/Hypopnea Index (AHI)
3.9; 6.4 0.022 sig
SECONDARY
Oxygen Desaturation Index (ODI)
5.2; 8.2 0.016 sig

Eligibility Criteria

Inclusion Criteria

  • 21+ years old
  • Chronic ResMed ASV therapy patient
  • Current ASV therapy for at least 4 weeks
  • Able to understand fully the study information and participation requirements
  • Provide signed informed consent

Exclusion Criteria

  • Acute cardiac decompensation
  • Acute myocardial infarction within last 3 months
  • Resuscitation within last 3 months
  • Stroke with swallowing disorders or persistent hemiparesis
  • Blood pressure test at end expiratory pressure (EEP) 10cmH2O not passed
  • Untreated restless legs syndrome
  • Alcohol or drug abuse
  • Known cancer
  • Pregnancy
  • Conditions that could interfere with patients participating in and completing the protocol and/or the investigator deems their enrolment unsuitable
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01405313). 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. Informational only — not medical advice.

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