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Home-Use Impact and Effectiveness of Cloud 9 (Cloud9)

Primary Purpose

Snoring

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cloud9
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Johns Hopkins Bayview - Asthma and Allegy Building

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cloud9 Snoring Treatment

Arm Description

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

Outcomes

Primary Outcome Measures

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.
Bed Partner Sleep Quality - Actigraphy
This will be assessed via activity monitoring measured by Actigraphs worn on the wrist.

Secondary Outcome Measures

Usage Time of the Cloud9 device
The Cloud9 device will be connected to a power logger and data collected at the end of the trial.

Full Information

First Posted
February 12, 2016
Last Updated
March 1, 2019
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT02688335
Brief Title
Home-Use Impact and Effectiveness of Cloud 9
Acronym
Cloud9
Official Title
Home-Use Impact and Effectiveness of Cloud 9
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding.
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is an interventional study in which patients with a history of habitual snoring use the Cloud9™ Continuous Positive Airway Pressure (CPAP) device that delivers a low level of continuous nasal air pressure between 2 cm H2O and 4 cm H2O, for about four weeks at their home. 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 Procedures Study Procedures Baseline Assessment: The study begins with a baseline assessment to determine whether each participant meets the entry criteria for the study. After consent, participant snorers will have a history and physical exam to confirm entry criteria and answer questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), Snore Outcomes Survey (SOS), and Stanford Sleepiness Scale (SSS) to assess their sleepiness and snoring. In a second step, snoring participants who initially meet the entry criteria will receive a full night Home Sleep Test (HST) to confirm snoring and to rule out sleep apnea or any other sleep related disorder. Participants who already performed a full night polysomnography (PSG) as a part of the earlier sleep lab study for the Cloud9 device (Treatment of Snoring NA_00073250) do not have to be re-screened, if the earlier PSG is not older than 36 months, and the participant's BMI remains within 3 kg/m2 of its original value. In parallel, the snorer's bed-partner will be asked to complete baseline questionnaires: ESS, PSQI, Spouse/Bed-partner Survey (SBPS), and supplement, SSS, and snore assessment according to Visual Analog Scale (VAS). Baseline Week: Snorers and bed-partners will be asked to wear Actigraphy watches for approximately one-week prior to the initiation of treatment at home with the study device. Home-Trial: At the end of the baseline week, snoring participants will be asked to use the device at home for 4 weeks. Usage data will be recorded by a power logger and read when returned to the study site at the end of study. Snoring participants will receive a study coordinator call on the day after night 1 of the home trial. Additionally, snoring participants will receive a coordinator call weekly thereafter, to assess the user experience with the device. Snorers and bed-partners will continue to wear Actigraphy monitors throughout the home-trial. Final Visit: At the end of the 4 weeks of home use, participants will return all study equipment to the sleep lab. Usage data from the data logger will be read for compliance rates. Snoring participants and their bed partners will also complete a final set of questionnaires as before (ESS, PSQI, SOS, SBPS and supplement. Bed partners will rate snoring using VAS. Snorers will also be asked to complete a Comfort and Acceptability Survey and the Sleep Apnea Quality of Life Index (SAQLI) Treatment related questions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cloud9 Snoring Treatment
Arm Type
Experimental
Arm Description
Snoring participants will be instructed to use the device as much as possible for 2 weeks.
Intervention Type
Device
Intervention Name(s)
Cloud9
Other Intervention Name(s)
inSleep Technologies
Intervention Description
Low-pressure Continuous Positive Airway Pressure (CPAP = 2 - 4 cm H2O).
Primary Outcome Measure Information:
Title
Snoring Severity
Description
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.
Time Frame
1 night
Title
Bed Partner Sleep Quality - Actigraphy
Description
This will be assessed via activity monitoring measured by Actigraphs worn on the wrist.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Usage Time of the Cloud9 device
Description
The Cloud9 device will be connected to a power logger and data collected at the end of the trial.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan R Schwartz, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Bayview - Asthma and Allegy Building
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21221
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with researchers outside the primary research group for secondary purposes.

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Home-Use Impact and Effectiveness of Cloud 9

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