Obstructive Sleep ApneaNCT04372329
Promoting the Use of CPAP Therapy Among OSA Patients
A study testing CPAP4HealthySleep system in people with Obstructive Sleep Apnea, run by Sarah Alismail at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA. However, up to 50% of patients who accept using CPAP therapy fail to adhere to it. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP4HealthySleep system
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 30 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of OSA
- Prescribed treatment of CPAP therapy
- Possession of a mobile phone that has multimedia messaging capabilities
- Capacity to consent.
Who cannot join
- Unable to speak and read English
Trial locations and contacts
1 site in 1 country.
United States1 site
Pomona Valley Hospital Medical Center Adults and Children Sleep Disorders Center
Claremont, California, 91711
About this study
Official title: A Tailored Sleep Behavior Change Support System to Promote the Use of Continuous Positive Airway Pressure Therapy: Theorizing the Solution
Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA. However, up to 50% of patients who accept using CPAP therapy fail to adhere to it. This study will evaluate an information systems (IS)-based solution that sends tailored, motivational, educational messages and tailored feedback messages to promote CPAP usage among noncompliant OSA patients. The primary aim of this study is to determine the efficacy of the proposed IS solution and its effect on fostering the use of CPAP therapy among OSA patients.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP4HealthySleep system
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP4HealthySleep systemBehavioural
Tailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy
| Study group | Role | What they receive |
|---|---|---|
| CPAP4HealthySleep: System 1 (ABAB) | Experimental | Participants in this group will first receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A). Next, they will receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B), re-introduction of type A for another two weeks, followed by re-introduction of type B for two weeks. Receives: Behavioral: CPAP4HealthySleep system |
| CPAP4HealthySleep: System 2 (BABA) | Experimental | Participants in this group will first receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B). Next, they will receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A), re-introduction of type B for another two weeks, followed by re-introduction of type A for two weeks. Receives: Behavioral: CPAP4HealthySleep system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CPAP usage
The average number of hours per week of CPAP usage.
Measured: During 19 weeks
CPAP compliance
Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.
Measured: 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start1 Jul 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Alismail
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sarah Alismail, Claremont Graduate University
- Investigators
- Sarah Alismail, MS, MPH, Principal investigator, Claremont Graduate University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372329
- Sponsor's protocol ID
- 3726
- Status last verified
- Aug 2022
- First submitted
- 25 Apr 2020
- Last updated
- 18 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tailored Sleep Behavior Change Support System to Promote the Use of Continuous Positive Airway Pressure Therapy: Theorizing the Solution
- ClinicalTrials.gov ID
- NCT04372329
- Acronym / sponsor ID
- 3726
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Sarah AlismailUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 4 May 2020 (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.
Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA. However, up to 50% of patients who accept using CPAP therapy fail to adhere to it. This study will evaluate an information systems (IS)-based solution that sends tailored, motivational, educational messages and tailored feedback messages to promote CPAP usage among noncompliant OSA patients. The primary aim of this study is to determine the efficacy of the proposed IS solution and its effect on fostering the use of CPAP therapy among OSA patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP4HealthySleep: System 1 (ABAB) | Experimental | Behavioral: CPAP4HealthySleep systemParticipants in this group will first receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A). Next, they will receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B), re-introduction of type A for another two weeks, followed by re-introduction of type B for two weeks. |
| CPAP4HealthySleep: System 2 (BABA) | Experimental | Behavioral: CPAP4HealthySleep systemParticipants in this group will first receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B). Next, they will receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A), re-introduction of type B for another two weeks, followed by re-introduction of type A for two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of OSA
- Prescribed treatment of CPAP therapy
- Possession of a mobile phone that has multimedia messaging capabilities
- Capacity to consent.
Key exclusion criteria (1 listed)
- Unable to speak and read English
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 |
|---|---|---|
| CPAP4HealthySleep systemTailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy | Behavioural | CPAP4HealthySleep: System 1 (ABAB), CPAP4HealthySleep: System 2 (BABA) |
Primary outcome
Change in CPAP usage
Time frame: During 19 weeks
The average number of hours per week of CPAP usage.
CPAP compliance
Time frame: 19 weeks
Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.
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 18 Aug 2022.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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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
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Sarah Alismail, MS, MPH principal investigator
Claremont Graduate 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 CPAP4HealthySleep system in people with Obstructive Sleep Apnea, run by Sarah Alismail 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 4 inclusion and 1 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 18 Aug 2022. 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?
Change in CPAP usage (time frame: During 19 weeks). 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 18 Aug 2022.