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Evaluation of WP200 With the Unified Probe (WP200U)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929447
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : September 19, 2014
Sponsor:
Information provided by (Responsible Party):
Itamar-Medical, Israel

Brief Summary:

The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated. The severity of the disorder is expressed by the Apnea Hypopnea Index (AHI) which is the number of Apnea/Hypopnea episodes per hours of actual sleep and the Respiratory Disturbances Index (RDI) which is an extended index incorporating in addition to the previous episodes also respiratory effort related arousal episodes. The high cost of in-lab full night PSG, together with long waiting lists for sleep studies, have led to the development of a variety of ambulatory sleep study systems.

The primary objective of the study is to evaluate the newly developed WP200 with the unified probe (WP200U) compared to the currently used configuration of WP200 that uses an incorporated Nonin oximetry module in the sleep lab or in the home sleep environment.


Condition or disease
Sleep Disorders

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Study Type : Observational
Actual Enrollment : 75 participants
Time Perspective: Prospective
Official Title: A Prospective, Comparative Study to Evaluate the Watch-PAT200 (WP200) With the Unified Probe (WP200U) Compared to the Currently Used Configuration of WP200 With the Nonin Oximetry Module
Study Start Date : October 2013
Actual Primary Completion Date : September 2014



Primary Outcome Measures :
  1. Sleep respiratory parameters [ Time Frame: 3 years ]
    pRDI, pAHI, ODI



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects, adults and children, with suspected sleep disorders who are referred to a sleep study and are willing to participate in this clinical study.

Additional non selective volunteers who are willing to participate in this clinical study and consent to undergo an overnight sleep study at their home.

Criteria

Inclusion Criteria:

  • Age between 5-90
  • Subjects that are able to read understand and sign the informed consent form of the study or by parents of subjects that are less than 18 years of age that are either referred or volunteering to undergo an overnight sleep study in the clinical sleep laboratory or at home

Exclusion Criteria:

  • Permanent pacemaker.
  • Severe lung disease.
  • Severe peripheral neuropathy.
  • Finger deformity that precludes adequate sensor appliance.
  • Using one of the following medications: short/Long acting nitrates (less than 3 hours before the sleep study) or alpha-adrenergic receptor blockers (less than 24 hours before the sleep study).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929447


Locations
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Israel
Carmel Medical Center
Haifa, Israel
Sponsors and Collaborators
Itamar-Medical, Israel
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Responsible Party: Itamar-Medical, Israel
ClinicalTrials.gov Identifier: NCT01929447    
Other Study ID Numbers: Carmel-002
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Itamar-Medical, Israel:
sleep disorders
sleep apnea
ambulatory device
WatchPAT
Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders