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

• Conditions: ESRD; Sleep Apnea; Oxygen Deficiency
• Interventions: Other: Observational

• Registration Number: NCT02987179
• Lead Sponsor: Renal Research Institute

Brief Summary

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

Not available

Study Timeline

• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-06
• Last Update Submitted: 2016-12-06
• Study First Posted: 2016-12-08
• Last Update Posted: 2016-12-08
• Primary Completion: 2017-03
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ESRD Patients	Observational	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Renal Research Institute; 🇺🇸 New York, New York, United States