Sleep DisorderNCT03984058
Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes
A study testing Lifestyle Intervention in people with Sleep Disorder and Pre Diabetes, run by Johns Hopkins University at 1 site in United States.
Trial summary
Recruitment strategies comparing different strategies. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 17 May 2021
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl
- Moderate-to-severe OSA [4% oxygen desaturation index (ODI) ≥ 20/h]
- Ability to provide informed consent
- Able to comply with all study procedures and be available for the study duration
- Availability of smart phone
Who cannot join
- BMI < 28 or ≥ 38 kg/m2
- Type 1 or Type 2 diabetes mellitus
- Pregnancy
- Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
- Prior or anticipated bariatric surgery
- Current use of PAP or oral appliance therapy for OSA
Show all 19Show fewer
- Commercial driver
- Report of a motor vehicle accident or near-miss due to sleepiness within 2 years
- Epworth Sleepiness Scale score10 > 18
- Current (prevalent) use of oral corticosteroids (within 1 month)
- Participation in a concurrent clinical trial
- Unstable medical conditions: uncontrolled angina and/or congestive heart failure, uncontrolled blood pressure or resistant hypertension [BP ≥ 160/100 among those with hypertension, requiring 3 or more meds], severe chronic obstructive pulmonary disease, cancer, or active psychiatric disease
- Other sleep disorders (e.g., circadian rhythm disorder, working night or rotation shift, short sleep duration based on self-reported habitual sleep patterns < 5 hrs/night)
- Use of supplemental oxygen during wakefulness or sleep
- Central sleep apnea (central apnea index ≥ 5/h) or Cheyne-Stokes respiration (> 10 minutes of continues period breathing) on the screening home sleep test Resting awake SpO2 < 90%
- Chronic opiate use.
- Use of illicit drug / marijuana use more than once per week
- Difficulty understanding or speaking English
- Anything that, in the opinion of the site investigator, would place the participant at increased risk or preclude a participant's ability to adhere to study protocols or complete the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Medicine, Johns Hopkins University
Baltimore, Maryland, 21224
About this study
Official title: Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes
Recruitment strategies comparing different strategies.
Read the detailed description
Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine the recruitment yields from electronic medical record (EMR) vs the general community. To assess the adherence to positive airway pressure (PAP) therapy among patients with prediabetes and moderate-to-severe OSA.
- Conditions
- Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea
- Being tested
- Lifestyle Intervention
- Keywords
- Pre-diabetes, Sleep Apnea, PAP Therapy, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Wake Disorders, Glucose Intolerance, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
A lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes.
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1 | Other | All enrolled participants will have participants' PAP usage monitored by Fusion Health using the ResMed AirView Remote Monitoring system. Fusion Health will provide individual care for each participant by monitoring daily PAP usage by all study participants. This assessment ensures routine follow-up of PAP adherence during the study. The responsibility for patient care during the study, however, will fall on clinical site staff with any needed assistance by the Fusion Health staff. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit. Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)
Determine recruitment yield from EMR versus the general community.
Measured: 1 year
Secondary outcomes (1)
Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system
Participants will have PAP usage monitored with the ResMed AirView Remote Monitoring system. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit. A phone contact or in-person visit will be scheduled if the following findings observed for ≥3 consecutive nights:
- Suboptimal adherence (< 5 hours per night);
- Mean leak is high (> 20 L/min); or treatment is not optimal (AHI ≥ 5 events/h)
Each participant will have a follow-up visit ~ 7 days after starting PAP therapy
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start1 Oct 2019
- Primary completion17 May 2021
- Study completion17 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Fusion Health
- Responsible party
- Sponsor
- Investigators
- Naresh Punjabi, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984058
- Sponsor's protocol ID
- IRB00199862
- Status last verified
- Nov 2020
- First submitted
- 10 Jun 2019
- Last updated
- 29 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Recruitment Strategies for a Randomized Controlled Trial in Sleep Apnea and Prediabetes
- ClinicalTrials.gov ID
- NCT03984058
- Acronym / sponsor ID
- IRB00199862
- Conditions
- Sleep Disorder, Pre Diabetes, Obstructive Sleep Apnea
- Keywords
- Pre-diabetes, Sleep Apnea, PAP Therapy, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Fusion Health
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 17 May 2021 (actual)
- Study completion
- 17 May 2021 (actual)
- First posted
- 12 Jun 2019 (actual)
- 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.
Recruitment strategies comparing different strategies.
Detailed description
Patients with prediabetes and moderate-to-severe Obstructive Sleep Apnea (OSA). To determine the recruitment yields from electronic medical record (EMR) vs the general community. To assess the adherence to positive airway pressure (PAP) therapy among patients with prediabetes and moderate-to-severe OSA.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1 | Other | Behavioral: Lifestyle InterventionAll enrolled participants will have participants' PAP usage monitored by Fusion Health using the ResMed AirView Remote Monitoring system. Fusion Health will provide individual care for each participant by monitoring daily PAP usage by all study participants. This assessment ensures routine follow-up of PAP adherence during the study. The responsibility for patient care during the study, however, will fall on clinical site staff with any needed assistance by the Fusion Health staff. An intervention will be required when PAP adherence decreases or if any other issues are identified that require a face-to-face visit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Prediabetes: A1c value of 6.0-6.4% and fasting glucose of 100-125 mg/dl
- Moderate-to-severe OSA [4% oxygen desaturation index (ODI) ≥ 20/h]
- Ability to provide informed consent
- Able to comply with all study procedures and be available for the study duration
- Availability of smart phone
Key exclusion criteria (19 listed)
- BMI < 28 or ≥ 38 kg/m2
- Type 1 or Type 2 diabetes mellitus
- Pregnancy
- Use of glucose-lowering or weight loss medications (e.g., metformin, orlistat, phentermine)
- Prior or anticipated bariatric surgery
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 |
|---|---|---|
| Lifestyle InterventionA lifestyle intervention program adapted from the Diabetes Prevention Program (DPP). Study participants will start lifestyle intervention on the day of initiating PAP therapy. The 3-month program will be followed: Patient-facing Online Platform: The program will be accessible to study participant via the Web or a Web application available for the Android and iOS devices. Behavioral Weight Loss Goals and Lessons: The program begins with an introductory session that presents the basic goals for the program followed by 12 weekly multimedia lessons. Submission of self-monitoring data: Participants will submit daily weight, caloric intake, and physical activity minutes at least weekly to the study website for 12 weeks. Automated Feedback: In response to the self-monitoring data, participants receive a weekly automated message that compares participants' self-reported values to participants' goals for weekly and overall weight loss, caloric intake, and physical activity minutes. | Behavioural | Study Arm 1 |
Primary outcome
Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR)
Time frame: 1 year
Determine recruitment yield from EMR versus the general community.
1 secondary outcome
Adherence to Pap Therapy as assessed by the ResMed AirView Remote Monitoring system
Time frame: 1 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
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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.
Naresh Punjabi, M.D. 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 Lifestyle Intervention in people with Sleep Disorder and Pre Diabetes, 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 5 inclusion and 19 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: finished, as of the sponsor's last update on 29 Oct 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recruitment Yield as assessed by number of participants enrolled from electronic medical records (EMR) (time frame: 1 year). 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 29 Oct 2021.