N/A
N=21
Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
Periodic Breathing · Breathing-Related Sleep Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01405313 ↗Enrolled (actual)
21
Serious AEs
2.4%
Results posted
Mar 2017
Primary outcome: Primary: Apnea/Hypopnea Index (AHI) — 3.9; 6.4 Events per hour — p=0.022
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Modified Adaptive Servoventilation Device (Device); Conventional Adaptive Servoventilation device (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- ResMed
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-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 |
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.
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
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.