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The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the Apnea Hyperpnoea Index (AHI) or Respiratory Disturbance Index (RDI) and measures of oxygen saturation during sleep.
Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. Associated features include loud snoring and fragmented non-refreshing sleep and have profound impact on quality of life, on safety on the roads and at work, and on the cardiovascular and metabolic systems.
The aim of the study is to test the hypothesis that a new device would produce a significant decrease in obstructive breathing events during sleep as indexed by the AHI/RDI and measures of oxygen saturation during sleep.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| keePAP | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| keePAP | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| AHI/RDI and oxygen saturation during sleep | Efficacy of the keePAP system in reducing the number of obstructive breathing events during sleep as indexed by the AHI and measures of oxygen saturation during sleep. | one night |
| Measure | Description | Time Frame |
|---|---|---|
| Patient comfort | Patients will be asked to report their sleep experience and if any difficulties or discomfort was encountered. | one night |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Asher Tal, MD | Soroka University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soroka Medical Center | Beersheba | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10450601 | Background | Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. The Report of an American Academy of Sleep Medicine Task Force. Sleep. 1999 Aug 1;22(5):667-89. No abstract available. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |