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

NCT01462084 | Completed Results FDA Device

• 1 other identifier: MA-01-10
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea; Central Sleep Apnea (Diagnosis); Chronic Opioid Use

Keywords

sleeping; opioid medications; positive airway pressure

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

  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).

  Up to 1 month

Secondary Outcomes (1)

• Patient Comfort

  Up to 1 month

Study Arms (2)

Adaptive Servo-Ventilation (ASV) then BiLevel PAP

EXPERIMENTAL

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); Device: Bi-Level PAP

Bi-Level PAP then Adaptive Servo-Ventilation (ASV)

EXPERIMENTAL

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); Device: Bi-Level PAP

Interventions

Adaptive servo-ventilation (ASV) DEVICE

Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.

Adaptive Servo-Ventilation (ASV) then BiLevel PAP; Bi-Level PAP then Adaptive Servo-Ventilation (ASV)

Bi-Level PAP DEVICE

Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.

Adaptive Servo-Ventilation (ASV) then BiLevel PAP; Bi-Level PAP then Adaptive Servo-Ventilation (ASV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ResMed: lead

Study Sites (1)

Stanford Center for Human Sleep Research

Redwood City, California, 94603, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea, Central; Disease

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Michelle Cao, DO, FAASM
• Organization: Stanford Sleep Medicine

michellecao2007@gmail.com

(650) 723-6601

Study Officials

• Michelle Cao, DO

  Stanford Center for Human Sleep Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 28, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)