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:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT02688335
Eligibility Criteria:
Inclusion Criteria:
* Patient is \> 18 years of age.
* Patient is willing and able to provide written Informed Consent utilizing a Patient Information and Consent form that has been reviewed and approved by a governing Institutional Review Board (IRB).
* Patient has a bed partner willing to participate in the study
* Patient has a history of habitual snoring (almost every night or every night) as determined by a bed-partner; bed-partner subjectively reports that snoring is a considerable burden for her/him.
* Patient has been pre-screened and demonstrates an Epworth Questionnaire (an assessment of daytime sleepiness; high number = greater sleepiness) score of less than 11, no history of witnessed apneas or nocturnal gasping/choking episodes and a BMI ≤ 35, or subjects with a BMI \>35 who have no significant sleep apnea already documented on an overnight sleep study.
Exclusion Criteria: (For subjects recruited from the previous inSleep protocol, the BMI must be in a range of ±3 kg/m2 of the earlier recorded value)
* Patient has been diagnosed with Chronic Obstructive Pulmonary Disease (COPD), asthma, emphysema or chronic bronchitis.
* Patient has a history of heart disease, heart attack or stroke.
* Patient has uncontrolled or poorly controlled hypertension.
* Patient has been diagnosed with Obstructive Sleep Apnea (OSA), defined as Apnea-Hypopnea Index (AHI) ≥ 15. Hypopnea is defined as a discernible reduction in flow that is associated with a greater than or equal to 4% desaturation.
* Pregnancy of the snoring participant, by self-report. If there is any doubt concerning status, a urine pregnancy test will be performed.
* Patient is currently participating in another clinical study for which follow-up is ongoing.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02688335
Study Brief:
Protocol Section:
NCT02688335