NCT02760680

Brief Summary

A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 16, 2017

Status Verified

March 1, 2017

Enrollment Period

3 months

First QC Date

April 20, 2016

Last Update Submit

March 15, 2017

Conditions

Sleep-Disordered Breathing

Keywords

Chronic Heart FailureSleep-Disordered BreathingPeripheral Arterial Tone

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea-Index (AHI)

    Index is stated per hour (/h)

    one night of sleep

Secondary Outcomes (31)

  • Sleep: Time in bed

    one night of sleep

  • Sleep: Total sleep time

    one night of sleep

  • Sleep: Sleep latency

    one night of sleep

  • Sleep: Rapid-Eye-Movement (REM) sleep latency

    one night of sleep

  • Sleep: latency to S3

    one night of sleep

  • +26 more secondary outcomes

Study Arms (2)

Polysomnography

PLACEBO COMPARATOR

The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.

Device: WatchPAT 200 (TM)Other: Polysomnography

Diagnostic Device (WatchPAT 200 (TM))

ACTIVE COMPARATOR

The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.

Device: WatchPAT 200 (TM)Other: Polysomnography

Interventions

WatchPAT 200 (TM)DEVICE

The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.

Also known as: PAT (TM) - Watch-PAT 200, Itamar-Medical Ltd., Israel
Diagnostic Device (WatchPAT 200 (TM))Polysomnography
PolysomnographyOTHER

The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.

Diagnostic Device (WatchPAT 200 (TM))Polysomnography

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • reduced left ventricular ejection fraction (LVEF) \< 45 %
  • indication for a polysomnography

You may not qualify if:

  • allergies against the device or parts of the device
  • psychogenic or neurological disorders which do not allow a sufficient patient compliance
  • osteogenetic disorders which do not allow a painless investigation
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

  • Bar A, Pillar G, Dvir I, Sheffy J, Schnall RP, Lavie P. Evaluation of a portable device based on peripheral arterial tone for unattended home sleep studies. Chest. 2003 Mar;123(3):695-703. doi: 10.1378/chest.123.3.695.

    PMID: 12628865BACKGROUND

Related Links

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Thomas Bitter, MD

    Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

    STUDY DIRECTOR

  • Florian Schindhelm

    Herz- und Diabeteszentrum NRW, Ruhr-Universitaet Bochum, Bad Oeynhausen, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med

Study Record Dates

First Submitted

April 20, 2016

First Posted

May 4, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2016

Last Updated

March 16, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)