Home-Use Impact and Effectiveness of Cloud 9

Withdrawn before enrolling · Not applicable

Conditions studied: Snoring

In brief

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.

Key facts

Study ID

NCT02688335

Run by

Johns Hopkins University

People needed

0

Starts

2018-06-30

Expected to finish

2019-06-01

Last updated by the study team

2019-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• Johns Hopkins Bayview - Asthma and Allegy Building — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.