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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02987179
• Other study ID #: RRI-16-002
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 6, 2016
• Last updated: December 6, 2016
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: Renal Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anoxia
• ESRD
• Oxygen Deficiency
• Sleep Apnea

Intervention

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

Locations

Country	Name	City	State
United States	Renal Research Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Renal Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No