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NCT02295306 · ClinicalTrials.gov registry record
Overnight Polysomnography and Respiratory Volume Monitor
A clinical trial of Obstructive Sleep Apnea (OSA), sponsored by Tufts Medical Center.
- Active
- Registry status
- 80
- Enrollment target
- 1
- Study location
NCT02295306: Active study of Obstructive Sleep Apnea (OSA), sponsored by Tufts Medical Center.
NCT02295306 is a study of Obstructive Sleep Apnea (OSA) that is active but no longer recruiting, run by Tufts Medical Center. The registered enrollment target is 80 participants, below the 585-participant average among 12 other Obstructive Sleep Apnea (OSA) trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02295306, a study of Obstructive Sleep Apnea (OSA), is active but no longer recruiting, sponsored by Tufts Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- 80 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DEVICE Respiratory Volume Monitor (RVM, ExSpiron)
Study Locations (1)
Massachusetts
- Tufts Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-06 |
| Est. Completion | 2026-07-31 |
What the registry record for NCT02295306 still lists
NCT02295306 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 585-participant average among 12 other Obstructive Sleep Apnea (OSA) trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Obstructive Sleep Apnea (OSA) appearing as the primary indexed condition, and to 1 intervention - of which Respiratory Volume Monitor (RVM, ExSpiron) is the first listed.
NCT02295306 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02295306 about?
NCT02295306 is a clinical study titled "Overnight Polysomnography and Respiratory Volume Monitor". 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...
What is the current status of trial NCT02295306?
This trial is currently active not recruiting. The enrollment target is 80 participants. The study started on 2013-06. Estimated completion is 2026-07-31.
What conditions does trial NCT02295306 study?
This clinical trial studies the following conditions: Obstructive Sleep Apnea (OSA).
What interventions are being tested in trial NCT02295306?
The interventions under investigation include: Respiratory Volume Monitor (RVM, ExSpiron) (DEVICE).
Who is sponsoring clinical trial NCT02295306?
This trial is sponsored by Tufts Medical Center, which has 169 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02295306 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02295306's enrollment target sits among peer trials
80 3rd of 12 higher than 10 of 12 other Obstructive Sleep Apnea (OSA) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obstructive Sleep Apnea (OSA) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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