Trial Outcomes & Findings for Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use (NCT NCT01462084)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Up to 1 month

Results posted on

2017-04-17

Participant Flow

All patients were recruited from a single sleep center in the United States.

Participant milestones

Participant milestones
Measure	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. 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 patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night.	Bi-Level PAP Bi-level PAP 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 patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night.
Overall Study STARTED	11	10
Overall Study Included for Analysis	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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 patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night.	Bi-Level PAP Bi-level PAP 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 patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night.
Overall Study Withdrawal by Subject	1	0
Overall Study Protocol Violation	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study Population n=18 Participants All study patients included in final analysis.
Age, Continuous	52.9 years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Adaptive Servo-Ventilation (ASV) n=18 Participants All patients received 1 night of therapy using Adaptive servo-ventilation (ASV) and 1 night of therapy using Bi-level 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.	Bi-Level PAP n=18 Participants 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.
Apnea Hypopnea Index (AHI)	2.5 events/hour Standard Deviation 3.5	16.3 events/hour Standard Deviation 20.9

SECONDARY outcome

Timeframe: Up to 1 month

Subjects completed patient-satisfaction questionnaires after each polysomnography (PSG) study. Satisfaction with PAP: 0=Very Dissatisfied, 100=Very Satisfied

Outcome measures

Outcome measures
Measure	Adaptive Servo-Ventilation (ASV) n=18 Participants All patients received 1 night of therapy using Adaptive servo-ventilation (ASV) and 1 night of therapy using Bi-level 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.	Bi-Level PAP n=18 Participants 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.
Patient Comfort	76.0 units on a scale Standard Deviation 27.2	67.8 units on a scale Standard Deviation 28.0

Adverse Events

Adaptive Servo-Ventilation (ASV)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bi-Level PAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michelle Cao, DO, FAASM

Stanford Sleep Medicine

Phone: (650) 723-6601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60