Servo-Ventilation In-lab PSG Evaluation

Completed · Not applicable

Conditions studied: Sleep Apnea Syndromes

In brief

Continuous Positive Airway Pressure (CPAP) is the most effective treatment for the Obstructive Sleep Apnea-Hypopnea Syndrome (OSAHS). CPAP stabilizes the airway and prevents instability and collapse. With a stable and patent airway, breathing continues in a normal manner, gas exchange is improved, and there is no disruption of sleep related to disturbed breathing. Auto Servo Ventilation (Auto SV) is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. The main features of the Auto SV mode include: * Normalization of ventilation by automatically adjusting Inspiratory Positive Airway Pressure (IPAP) pressure to achieve a target ventilation. IPAP is increased or decreased to help stabilize the ventilation. * Provision of timed, back-up breaths during central apneas. The optimal back-up rate is automatically determined by the device based on the patient's breathing. * Automatic control of Expiratory Positive Airway Pressure (EPAP) to treat obstructive events. Several manufacturers produce these types of devices. The algorithms used to determine the IPAP, EPAP and minimum respiratory rate are different. The largest number of these devices currently in use are the BiPAP AutoSV Advanced System One (Philips Respironics, Murrysville PA) and the Variable positive airway pressure (VPAP) Adapt (ResMed Corp., San Diego CA).

Key facts

Study ID

NCT02808338

Run by

Philips Respironics

People needed

25

Starts

2015-11-09

Expected to finish

2017-07-06

Last updated by the study team

2019-03-19

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide consent
• Age ≥ 21
• Currently prescribed servo ventilation therapy at home
• At least two weeks of recent adherence and efficacy data from PAP device demonstrating adequate use of therapy (at least 4 hours of use per night and use on at least 9 of 14 nights)
• Current device compliance report demonstrating residual Apnea-Hypopnea Index (AHI) of 5 or more

You may not qualify if…

• Participants who are acutely ill, medically complicated or who are medically unstable
• Participants in whom PAP therapy is otherwise medically contraindicated
• Participants who are claustrophobic
• Symptomatic ("Symptomatic" defined as hospitalized for heart failure or a change in cardiac medications, within the last two months) chronic heart failure (NYHA 2-4) and reduced LVEF≤45%, AND moderate to severe predominant central sleep apnea
• Participants with previously diagnosed respiratory failure or respiratory insufficiency and who are known to have elevated arterial carbon dioxide levels while awake (PaCO2 ≥ 55mmHg).
• Participants requiring any kind of oxygen therapy
• Participants who have had surgery of the upper airway, nose, sinus, eyes, or middle ear within the previous 90 days
• Participants with untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic limb movement syndrome, or restless legs syndrome (PLMI > 10).

Where it is running

• University of Arizona School of Medicine — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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