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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07492420
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis with mild obstructive sleep apnea (AHI 5-14.9)
2. PSG or HST performed within last 24 months
3. Individuals aged 18 or older
4. Must routinely sleep on a standard mattress and must be able to accommodate the width of the MedCline Sleep System (30")
5. Must be in overall good health, with no significant medical conditions that would interfere with the study procedures or the ability to sleep safely using the MedCline Sleep System
6. Ability to provide written informed consent in accordance with IRB principles
7. Must be stable on any medications for at least 3 months prior to the date of consent
Exclusion Criteria:
1. Diagnosis of moderate to severe OSA (AHI \>15) or central sleep apnea
2. Has undergone surgical procedures for sleep apnea within the last six months
3. Clinically significant cardiac or respiratory conditions that may interfere with the study intervention or outcomes.
4. Chronic pain or musculoskeletal disorders, e.g., spinal deformities, scoliosis, kyphosis, back injuries, spinal compressions, or injuries that may affect their ability to sleep comfortably in a lateral position
5. Pregnant or planning to become pregnant during study period
6. Any conditions or circumstances that require frequent night-time awakenings (e.g., nocturia, caregiving responsibilities, or other health issues)
7. Unable or unwilling to use the MedCline Sleep System as required by the study protocol
8. Currently using substances or medications known to significantly alter sleep architecture or respiratory function (e.g., sedatives, narcotics, or alcohol dependency)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07492420
Study Brief:
Protocol Section:
NCT07492420