SnoringCloud9NCT02688335
Home-Use Impact and Effectiveness of Cloud 9
A study testing Cloud9 in people with Snoring, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Cloud9
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2018to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview - Asthma and Allegy Building
Baltimore, Maryland, 21221
About this study
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.
Read the 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.
- Conditions
- Snoring
- Being tested
- Cloud9
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cloud9Device
Also called inSleep Technologies
Low-pressure Continuous Positive Airway Pressure (CPAP = 2 - 4 cm H2O).
| Study group | Role | What they receive |
|---|---|---|
| Cloud9 Snoring Treatment | Experimental | Snoring participants will be instructed to use the device as much as possible for 2 weeks. Receives: Device: Cloud9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 night
Bed Partner Sleep Quality - Actigraphy
This will be assessed via activity monitoring measured by Actigraphs worn on the wrist.
Measured: 4 weeks
Secondary outcomes (1)
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start30 Jun 2018
- Primary completionJun 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: Lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan R Schwartz, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688335
- Sponsor's protocol ID
- IRB00052615
- Acronym
- Cloud9
- Status last verified
- Mar 2019
- First submitted
- 12 Feb 2016
- Last updated
- 4 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared with researchers outside the primary research group for secondary purposes.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-Use Impact and Effectiveness of Cloud 9
- ClinicalTrials.gov ID
- NCT02688335
- Acronym / sponsor ID
- Cloud9 / IRB00052615
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cloud9 Snoring Treatment | Experimental | Device: Cloud9Snoring participants will be instructed to use the device as much as possible for 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cloud9Also: inSleep TechnologiesLow-pressure Continuous Positive Airway Pressure (CPAP = 2 - 4 cm H2O). | Device | Cloud9 Snoring Treatment |
Primary outcome
Snoring Severity
Time frame: 1 night
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
Time frame: 4 weeks
This will be assessed via activity monitoring measured by Actigraphs worn on the wrist.
1 secondary outcome
Usage Time of the Cloud9 device
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2019.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with researchers outside the primary research group for secondary purposes.
Related trials for Snoring
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Not yet recruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
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Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan R Schwartz, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cloud9 in people with Snoring, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snoring Severity (time frame: 1 night). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.