Home-Use Impact and Effectiveness of Cloud 9
NCT02688335 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-03-04
Summary
This is an interventional study in which patients with a history of habitual snoring will use the low-pressure CPAP device at home for about 4 weeks. This study is designed to document the adherence of the snorer, the acceptance and comfort of the therapy, and bed partners' subjective report of improvement in sleep quality, and/or reduction or elimination of snoring. Study outcomes will consist of an assessment of the nightly usage time, and questionnaires that the snorer and the bed-partner have to complete before the start of the study and at the end of the study period.
Conditions
- Snoring
Interventions
- DEVICE
-
Cloud9
Low-pressure Continuous Positive Airway Pressure (CPAP = 2 - 4 cm H2O).
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Alan R Schwartz, MD · Johns Hopkins University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-06-30
- Primary Completion
- 2019-06-30
- Completion
- 2019-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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