NCT01690429

Brief Summary

Photoplethysmography is an easy non-invasive method to detect the pulse wave amplitude (PWA) from a finger. This can be measured using the Somnocheck micro system. A pulse wave amplitude decrease (PWAD) is considered to be a marker for autonomic activation. Detecting the PWAD is a surrogate marker for waking reactions (arousal) which eventually will contribute to assess sleep disruption and resulting performance deterioration. Arousal and performance deterioration and its possible improvement under continuous positive airway pressure (CPAP) therapy will be determined in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable

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

June 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

September 19, 2012

Last Update Submit

November 13, 2013

Conditions

Obstructive Sleep Apnea

Keywords

Arousal detectionPulse Wave AmplitudeObstructive Sleep ApneaDaytime sleepinessCardiorespiratory risk

Outcome Measures

Primary Outcomes (1)

  • pulse wave amplitude (PWA)

    8 hours

Study Arms (1)

OSA Patients

OTHER
Device: Somnocheck micro

Interventions

Somnocheck microDEVICE

Study nights in sleep lab with standard polysomnography plus Somnocheck micro. The Somnocheck micro is a device with pulse oxymetry and nasal cannula, which can be worn like a wristwatch. It records information about sleep disordered breathing, oxygen saturation, and pulse wave.

OSA Patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obstructive Sleep Apnea (AHI \>5)

You may not qualify if:

  • Suspected acute cardiac, pulmonary or neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helios Klinik Hagen

Hagen, North Rhine-Westphalia, 58091, Germany

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveDisorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Karl Heinz Rühle, Prof. Dr.

    Helios Klinik Hagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 19, 2012

First Posted

September 21, 2012

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations

DE(1)