Status:
COMPLETED
Evaluating an Under-mattress Sleep Monitor Compared to a Peripheral Arterial Tonometry Device in the Diagnosis of Obstructive Sleep Apnea
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Withings
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
22+ years
Brief Summary
A device has been developed which is placed under the mattress, thereby escaping contact with patient, which enables monitoring of sleep activity and has been shown in some studies to provide an estim...
Detailed Description
The design will be a prospective test of two diagnostic testing strategies. The tests will take place in the same patient concurrently, so the patient's results from one test will serve as the compara...
Eligibility Criteria
Inclusion
- Clinician suspects of having OSA due to presence of any:
- 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
- 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
Key Trial Info
Start Date :
April 22 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 20 2021
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04778748
Start Date
April 22 2021
End Date
December 20 2021
Last Update
May 5 2022
Active Locations (1)
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1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905