Overnight Polysomnography and Respiratory Volume Monitor

NCT02295306 | Active Not Recruiting

• 1 other identifier: IRB # 10880
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disordered breathing; specifically obstructive sleep apnea (OSA) is a disease affecting 8-12% of the general population and often more than 70% of the bariatric surgical population. OSA is characterized by the repetitive collapse of the upper airway, causing a reduction or cessation in airflow and decreases in oxygen saturation. These events are resolved by arousals from sleep, reducing sleep quality and leading to excessive daytime sleepiness. An in-laboratory polysomnography (PSG) is the gold standard for the diagnosis of OSA. Previous studies have established obstructive sleep apnea (OSA) as a potential independent risk factor for postoperative complications, adverse surgical outcomes, and longer hospital stays. Patients with OSA have an increase in postoperative complications, the most frequent being oxygen desaturation, postoperative atelectasis and increased postoperative pain. Despite the clear risks, OSA remains under diagnosed with an estimated 25-30% of patients at a high risk for OSA. It has been suggested that OSA events may be even more frequent post operatively because of the residual effects of anesthesia and the use of potent pain medications such as opioids. Postoperatively apneas often go undetected and untreated. The use of supplemental O2 may mask any desaturations and there is no convenient technology to noninvasively monitor ventilation to detect apnea and hypopnea in post-surgical patients. New advances in technology and digital signal processing have led to the development of an impedance based Respiratory Volume Monitor (RVM). The RVM (ExSpiron™, Respiratory Motion, Inc.; Waltham, MA) has been shown to provide accurate real-time, continuous, non-invasive measurements of tidal volume (TV), minute ventilation (MV) and respiratory rate (RR). Our main hypotheses are that the non-invasive, impedance-based RVM monitor will accurately reflect TV, RR and MV during sleep and will detect apneas and hypopneas accurately.

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

OSA, polysomnography, ExSpiron monitor

Outcome Measures

Primary Outcomes (1)

• Agreement between number and duration of apnea events measured as AHI (apnea hypopnea index) assessed by standard polysomnography versus Exspiron monitor

  Duration of polysomnography study, usually 1 overnight assessment

Secondary Outcomes (1)

• Ability of the Exspiron monitor to distinguish between central and obstructive apnea events. There is no unit measurement for this comparison

  Duration of polysomnography study, usually 1 overnight assessment

Interventions

Respiratory Volume Monitor (RVM, ExSpiron) DEVICE

Connecting patient to the ExSpiron monitor and continuous ExSpiron data collection during the patient's polysomnography (PSG)

Eligibility Criteria

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

Study Population

All adult patients referred to the sleep laboratory at Tufts Medical Center for a standard polysomnogram (PSG) are eligible to be recruited.

You may qualify if:

• Adult Patients referred to the sleep lab for a polysomnography for suspicion of sleep disordered breathing aged ≥ 18 years. Ability to provide written informed consent.

You may not qualify if:

• \- Patients not competent to give informed consent, patients with implantable electronic devices, such as pacemakers, stimulators, etc. pregnant or lactating women.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Respiratory Motion, Inc.: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Roman Schumann, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: November 20, 2014
• Study Start: June 1, 2013
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

US (1)