A Study to Evaluate an Under-mattress Sleep Monitor Vs. a Home Sleep Apnea Test to Diagnose Obstructive Sleep Apnea

Overview

About this study

The purpose of this study is to eEvaluate an under-mattress sleep monitor compared to a peripheral arterial tonometry home sleep apnea test device in the diagnosis of obstructive sleep apnea.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 22 years old.
  • STOP-BANG ≥ 3.
  • Overnight oximetry with ODI ≥ 5.
  • STOP-BANG≥ 2 and one or more of: disrupted sleep, cognitive complaints, paroxysmal or prior atrial-fibrillation (now in NSR), stroke, TIA.
  • Has a smartphone capable of running both Withings and Itamar’s app.
  • Stable sleeping quarters and schedule (i.e., no overnight shifts) for at least 7 days.
  • Domicile has capable wireless internet service.

Exclusion Criteria:

  • ≤ 22 years old.
  • Uses short-acting nitrates within 3 hours of the study.
  • Has a permanent pacemaker
  • Atrial fibrillation or sustained supraventricular arrhythmias.
  • Known congestive heart failure Class ≥ 1, or known LVEF < 45%.
  • Sustained hypoxemia or hypoventilation (results of RA daytime ABG show SaO2 < 90% or PaCO2 > 45 mmHg, or overnight oximetry shows mean SaO2 < 90%).
  • Advanced pulmonary disease (COPD GOLD stage ≥ II*, pulmonary fibrosis with GAP ≥ 1 or significant dyspnea on exertion.
  • *https://goldcopd.org/wp-content/uploads/2018/02/WMS-GOLD-2018-Feb-Final-to-print-v2.pdf.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Timothy Morgenthaler, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Paul Timm

(507) 266-6627

Timm.Paul@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20514763

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