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Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ResMed
ClinicalTrials.gov Identifier:
NCT01462084
First received: October 26, 2011
Last updated: April 13, 2017
Last verified: April 2017
  Purpose
Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the chronic use of opioid medications

Condition Intervention
Obstructive Sleep Apnea Central Sleep Apnea (Diagnosis) Chronic Opioid Use Device: Adaptive servo-ventilation (ASV) Device: Bi-Level PAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use

Resource links provided by NLM:


Further study details as provided by ResMed:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) [ Time Frame: Up to 1 month ]
    Subjects completed 2 overnight sleep studies (polysomnography (PSG)). The Apnea Hypopnea Index (AHI) metric is collected from the PSG study. Patients were equally distributed according to the therapy used first (ASV then Bi-Level or Bi-Level then ASV).


Secondary Outcome Measures:
  • Patient Comfort [ Time Frame: Up to 1 month ]
    Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied


Enrollment: 21
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adaptive Servo-Ventilation (ASV) then BiLevel PAP
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
Device: Adaptive servo-ventilation (ASV)
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.
Device: Bi-Level PAP
Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.
Experimental: Bi-Level PAP then Adaptive Servo-Ventilation (ASV)
Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
Device: Adaptive servo-ventilation (ASV)
Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.
Device: Bi-Level PAP
Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.

Detailed Description:

The trial seeks to determine the efficacy and patient comfort of ASV and bi-level positive airway pressure (PAP) modes for the treatment of obstructive sleep apnea (OSA), complicated by CSA secondary to opioid use. Subjects will be randomized to one of two groups, utilizing a cross-over design to evaluate the two modes with the subject as their own control.

Subjects will be asked to undergo two PSG studies; one with ASV titration and one with bi-level treatment, using the current pressure prescription. The study comprises two visits. Subjects will be asked to complete patient satisfaction questionnaires following their PSG studies. It is anticipated that total subject participation will be no longer than one month.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Taking opioid medications for at least 6 months. Opioid medications include but are not limited to: oxycodone, fentanyl, methadone, levorphanol, hydromorphone, and morphine
  • Using bi-level PAP for at least 30 days

Exclusion Criteria:

  • Primary heart or lung disease, for example: chronic obstructive pulmonary disease, pulmonary fibrosis, severe heart failure, uncorrected congenital heart disease, pulmonary hypertension
  • Primary neurologic disease, for example: neuromuscular disease, previous stroke or cognitive impairment
  • Narcolepsy
  • Acute upper respiratory tract infection
  • Pregnant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462084

Locations
United States, California
Stanford Center for Human Sleep Research
Redwood City, California, United States, 94603
Sponsors and Collaborators
ResMed
Investigators
Principal Investigator: Michelle Cao, DO Stanford Center for Human Sleep Research
  More Information

Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT01462084     History of Changes
Other Study ID Numbers: MA-01-10
Study First Received: October 26, 2011
Results First Received: October 19, 2016
Last Updated: April 13, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to share IPD with other researchers

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by ResMed:
sleeping
opioid medications
positive airway pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Apnea, Central
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 23, 2017