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

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.

Study Overview

• Status: Unknown
• Conditions: Sleep Apnea; ESRD; Oxygen Deficiency
• Intervention / Treatment: Other: Observational

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Renal Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chronic hemodialysis patients

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Observational; Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identifying Intradialytis desaturation episodes	• To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.	1 week

Collaborators and Investigators

• Sponsor: Renal Research Institute

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Estimate): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: RRI-16-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No