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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT01554904
Eligibility Criteria:
Inclusion Criteria:
* Patients with a history of loud snoring but no observed breathing pauses by bed partner (or only very mild obstructive sleep apnea on a previous sleep study within the prior year) will be enrolled.
* Very mild sleep apnea is defined here as an apnea-hypopnea index (AHI) \< 10/hour).
* This assumes that the AHI is computed using hypopnea defined as a 30% drop in the flow signal associated with a 4% or greater arterial oxygen desaturation.
Exclusion Criteria:
* Prior upper airway surgery
* Daytime sleepiness (Epworth sleepiness scale \>12/24), (obesity BMI \> 35 kg/M2)
* Significant arterial oxygen desaturation defined as 5 minutes or more with an arterial oxygen desaturation less than 88%
* Severe insomnia with less than 4 hours of sleep per night
* Uncontrolled psychiatric disorder
* Any disorder causing facial weakness
* Pregnancy
* Temporal mandibular joint problems.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01554904
Study Brief:
Protocol Section:
NCT01554904