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Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis

NCT ID: NCT02987179

Last Updated: 2016-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-12-31

Brief Summary

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The clinical diagnosis of sleep apnea is difficult among ESRD patients since the characteristic clinical features of sleep apnea may be absent and since sleep-related symptoms, such as fatigue and sleepiness, may be attributed to kidney failure. However, the evaluation of patients with possible sleep apnea is the same among ESRD patients as in the general population.

Detailed Description

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Conditions

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ESRD Sleep Apnea Oxygen Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ESRD Patients

The following inclusion criteria must be met for each subject.

* Age ≥18 years and able to give written informed consent to the study
* On chronic hemodialysis for ≥ 90 days at time of enrollment
* Ability to read
* Consent to have video recording taken during study visit

Observational

Intervention Type OTHER

Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records

Interventions

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Observational

Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥18 years and able to give written informed consent to the study
* On chronic hemodialysis for ≥ 90 days at time of enrollment
* Ability to read
* Consent to have video recording taken during study visit

Exclusion Criteria

* Subjects with cognitive impairment to consent
* Sickle cell anemia
* Prescription of nasal oxygen
* Simultaneous participation in another clinical trial that may affect breathing frequency/patterns, blood oxygenation, sleep/wake cycle or other parameters related to the outcomes of interest to this study
* Use of a breathing device, e.g. CPAP
* Central venous catheter used as vascular access for hemodialysis
* Artificial fingernails (may disturb the measurement of the WatchPAT)
* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
* Permanent pacemaker
* Sustained non-sinus cardiac arrhythmias.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renal Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renal Research Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RRI-16-002

Identifier Type: -

Identifier Source: org_study_id