Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 2:40 PM
NCT ID:
NCT02032706
Eligibility Criteria:
The inclusion criteria are:
* be between the age of 18 and 75 years,
* have been diagnosed with Obstructive Sleep Apnea (OSA) during polysomnography at a designated sleep center within 4 months of their enrollment,
* have not received treatment with any OSA therapy for more than 3 days within the past month,
* have an overall Apnea-Hypopnea Index (AHI) \> 10 and hypopneas requiring \>3% oxygen desaturation,
* having a non-supine Apnea-Hypopnea Index (AHI) \< 15 if Continuous Positive Airway Pressure has not been attempted,
* have a overall AHI divided by the non-supine AHI \> 1.5,
* had an Epworth Sleepiness Score of 5 or more at the time of diagnosis and at the start of therapy,
* Change in weight of no more than 5 pounds since the diagnostic PSG
* access to a computer and the Internet
* sleep is sometime between 8 P.M. to 9 A.M. Monday through Friday in the same bed
Exclusion Criteria:
* Neck, back or should pain which would impact ability to sleep laterally each night
* Body mass index \> 35
* suffering from neurological disorders which result in ticks or tremors
* diagnosed with congestive heart failure or chronic obstructive pulmonary disease
* suffered from a stroke within the previous 12 months
* taking or planning to take narcotic medications
* unfamiliar with use of internet browsers
* travel (i.e., foreign or cruise ship) which would limit internet or mail access
* planned medical procedures (e.g., surgery) which would limit device use during the scheduled 30-day study period or introduce the need for narcotic pain medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02032706
Study Brief:
Protocol Section:
NCT02032706