Sleep Disorders Clinical Trial
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
NCT number | NCT01929447 |
Other study ID # | Carmel-002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | August 20, 2013 |
Last updated | September 18, 2014 |
Start date | October 2013 |
Verified date | September 2014 |
Source | Itamar-Medical, Israel |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Observational |
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 5 Years to 90 Years |
Eligibility |
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). |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | Carmel Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Itamar-Medical, Israel |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sleep respiratory parameters | pRDI, pAHI, ODI | 3 years | No |
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