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Overnight Polysomnography and Respiratory Volume Monitor

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 31, 2025 → Dec 31, 2027
See other at-risk trials from Tufts Medical Center

Record History

  1. Notable Primary completion pushed from Dec 31, 2025 to Dec 31, 2027 Completion pushed from Jul 31, 2026 to Jul 31, 2028 · Eligibility criteria expanded, about 1 word Show 2 more changesShow less
    • Completion pushed from Jul 31, 2026 to Jul 31, 2028
    • Eligibility criteria expanded, about 1 word
  2. Notable Primary completion date: Dec 31, 2024 to Dec 31, 2025 Completion date: Jul 31, 2025 to Jul 31, 2026v12 Show 1 more changeShow less
    • Completion date: Jul 31, 2025 to Jul 31, 2026
  3. Notable Primary completion date: Dec 31, 2023 to Dec 31, 2024 Completion date: Jul 31, 2024 to Jul 31, 2025v11 Show 1 more changeShow less
    • Completion date: Jul 31, 2024 to Jul 31, 2025
  4. Notable Primary completion date: Dec 2022 to Dec 31, 2023 Completion date: Jul 2023 to Jul 31, 2024v10 Show 1 more changeShow less
    • Completion date: Jul 2023 to Jul 31, 2024
  5. Notable Primary completion date: Dec 2021 to Dec 2022 Completion date: Jul 2022 to Jul 2023v9 Show 1 more changeShow less
    • Completion date: Jul 2022 to Jul 2023
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Primary completion date: Dec 2020 to Dec 2021 Completion date: Dec 2021 to Jul 2022v8 Show 1 more changeShow less
    • Completion date: Dec 2021 to Jul 2022
  2. Notable Primary completion date: Dec 2019 to Dec 2020 Completion date: Dec 2019 to Dec 2021v7 Show 1 more changeShow less
    • Completion date: Dec 2019 to Dec 2021
  3. Notable Primary and study completion dates: Dec 2018 to Dec 2019v6
  4. Notable Primary and study completion dates: Dec 2017 to Dec 2018v5
  5. Minor Primary and study completion dates: Jun 2017 to Dec 2017v4
  6. Notable Primary completion date: Jun 2015 to Jun 2017 Completion date: Jun 2016 to Jun 2017v3 Show 1 more changeShow less
    • Completion date: Jun 2016 to Jun 2017
  7. Minor Trial status: Recruiting to Active, Not Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT02295306
Lead Sponsor Tufts Medical Center
Collaborators: Respiratory Motion, Inc.
Conditions Obstructive Sleep Apnea (OSA)
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov