- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01690429
Arousal Analysis by Pulse Wave Amplitude in Patients With Obstructive Sleep Apnea
Arousalanalyse Mittels Pulswellenamplitude Bei Patienten Mit Obstruktiver Schlafapnoe
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients from the sleep laboratory with verified obstructive sleep apnea syndrome (OSAS) will be asked to participate in this study.
A device is used to determine autonomic arousal over night (SOMNOcheck micro). The Somnocheck micro records oxygen saturation as well as pulse frequency and breathing, and calculates an autonomic arousal index (AAI). Somnocheck measurements will take place in two nights (baseline and with CPAP) and parallel to a standard polysomnography (PSG). The PSG provides data to analyze the arousal frequency according to ASDA rules, which will then be compared to the AAI.
Performance is determined twice (prior and after CPAP therapy) by the use of a steering simulator programme (DASS). Differences in arousal will be correlated with differences in performance (deviation from the road, reaction time). The subjects are also asked to fill out the Epworth Sleepiness Scale (ESS) twice, prior and after therapy. Aim is to compare Somnocheck and PSG measurements and daytime sleepiness with DASS and ESS.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
NRW
-
Hagen, NRW, Germany, 58091
- Helios Klinik Hagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Obstructive Sleep Apnea (AHI >5)
Exclusion Criteria:
- Suspected acute cardiac, pulmonary or neurologic disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: OSA Patients
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pulse wave amplitude (PWA)
Time Frame: 8 hours
|
8 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Karl Heinz Rühle, Prof. Dr., Helios Klinik Hagen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SOMNOcheck-2012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obstructive Sleep Apnea
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
Mauro ManconiCompletedObstructive Sleep Apnea Syndrome | Sleep Apnea, Obstructive | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | OSAHSwitzerland
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
State Budgetary Healthcare Institution, National...RecruitingObstructive Sleep Apnea | Obstructive Sleep Apnea-hypopnea | Obstructive Sleep Apnea-hypopnea SyndromeRussian Federation
-
The Hospital for Sick ChildrenCompleted
-
Cryosa, Inc.Active, not recruitingObstructive Sleep Apnea of AdultPanama, Paraguay
-
State Key Laboratory of Respiratory DiseaseCompletedObstructive Sleep Apnea of AdultChina
-
Somnics, Inc.UnknownObstructive Sleep Apnea of AdultTaiwan
-
ApnimedCompletedOSA - Obstructive Sleep ApneaUnited States
Clinical Trials on Somnocheck micro
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknownSleep Apnea, Obstructive | Resistant HypertensionItaly
-
Cytrellis Biosystems, Inc.CompletedWrinkle | Facial and Neck Skin LaxityUnited States
-
Cytrellis Biosystems, Inc.Completed
-
Federal State Budgetary Institution NATIONAL MEDICAL...Active, not recruitingArterial HypertensionRussian Federation
-
Cairo UniversityCompletedDiabetic Retinopathy | Macula EdemaEgypt
-
Beijing HospitalCompletedRotator Cuff Shoulder Syndrome and Allied Disorders
-
Case Comprehensive Cancer CenterCompleted
-
Peking University Third HospitalNot yet recruitingArticular Cartilage DefectsChina
-
Al-Azhar UniversityEnrolling by invitationAccerleration of Tooth MovementEgypt
-
Milton S. Hershey Medical CenterNot yet recruitingAttitudes | Knowledge | PracticeUnited States