Home-Use Impact and Effectiveness of Cloud 9

NCT02688335 | Withdrawn FDA Device

• 1 other identifier: IRB00052615
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Snoring

Outcome Measures

Primary Outcomes (2)

• Snoring Severity

  Snoring intensity will be assessed from standard polysomnography (if completed during previous trial), otherwise a WatchPAT device will be used at home for one night to measure sleep and snoring. The WatchPAT is a watch-like device worn on the wrist, which includes finger sensor to monitor oxygen saturation.

  1 night

• Bed Partner Sleep Quality - Actigraphy

  This will be assessed via activity monitoring measured by Actigraphs worn on the wrist.

  4 weeks

Secondary Outcomes (1)

• Usage Time of the Cloud9 device

  4 weeks

Study Arms (1)

Cloud9 Snoring Treatment

EXPERIMENTAL

Snoring participants will be instructed to use the device as much as possible for 2 weeks.

Device: Cloud9

Interventions

Cloud9 DEVICE

Low-pressure Continuous Positive Airway Pressure (CPAP = 2 - 4 cm H2O).

Also known as: inSleep Technologies

Cloud9 Snoring Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Bayview - Asthma and Allegy Building

Baltimore, Maryland, 21221, United States

Location

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Alan R Schwartz, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2016
• First Posted: February 23, 2016
• Study Start: June 30, 2018
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: March 4, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)