## Protocol Section
### Identification Module
**NCT ID:** NCT02987179

**Brief Title:** Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis

**Official Title:** Identification of Desaturation Episodes by Means of Continuous Measurement of Oxygen Saturation During Hemodialysis

#### Organization Study ID Info
**ID:** RRI-16-002
#### Organization
**Class:** OTHER
**Full Name:** Renal Research Institute
### Status Module
#### Completion Date
**Date:** 2017-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** ENROLLING_BY_INVITATION
#### Last Update Post Date
**Date:** 2016-12-08

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2017-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2016-12

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2016-12-08
**Type:** ESTIMATED
**Study First Submit Date:** 2016-12-06
**Study First Submit QC Date:** 2016-12-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Renal Research Institute

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- ESRD

- Sleep Apnea

- Oxygen Deficiency

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Other: Observational

**Label:** ESRD Patients

### Interventions

#### Intervention 1

**Arm Group Labels:**

- ESRD Patients

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

**Name:** Observational

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** • To determine the sensitivity and specificity of the CLM for identifying intradialytic desaturation episodes, using the WatchPAT device as the reference method.

**Measure:** Identifying Intradialytis desaturation episodes

**Time Frame:** 1 week

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Chronic hemodialysis patients

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Renal Research Institute

**State:** New York

**Zip:** 10065

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M4361

- Name: Apnea

- Relevance: LOW

- As Found: Unknown

- ID: M15694

- Name: Sleep Apnea Syndromes

- Relevance: LOW

- As Found: Unknown

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Oxygen Deficiency

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000860

- Term: Hypoxia

### Misc Info Module

- Version Holder: 2024-05-24
