Obstructive Sleep Apnea (OSA)NCT02314858
Tailored Treatment to Enhance Risk Perception in Sleep Apnea
A study testing Brief Personalized Video (BPV), Non-Personalized Video (NPV) and Treatment as Usual (TAU) in people with Obstructive Sleep Apnea (OSA), run by National Jewish Health at 1 site in United States.
Trial summary
Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious medical condition with significant medical and psychological consequences, including diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is Positive Airway Pressure therapy (PAP). Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Brief Personalized Video (BPV), Non-Personalized Video (NPV) and Treatment as Usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to Mar 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Polysomnography (PSG) confirmed diagnosis of Obstructive Sleep Apnea (OSA)
- choice of PAP as preferred treatment
- judged by sleep physicians to be responders to PAP
- participants will be considered responders to PAP if they have an AHI of less than 5, do not snore, and have an arousal index of less than 10 when titrated to the proper pressure of PAP
Who cannot join
- Apnea-Hypopnea Index (AHI) < 15 on the diagnostic PSG and no daytime functional symptoms or associated cardiovascular disease
- a sleep disorder other than OSA that causes arousals from sleep (e.g., periodic limb movements, restless legs syndrome, insomnia)
- a current substance abuse problem
- a serious sleep-disruptive medical condition (e.g., end stage renal failure, severe Chronic Obstructive Pulmonary Disease (COPD), severe asthma)
- significant global cognitive impairment
- history of or current diagnosis of psychosis, bipolar disorder, or borderline, schizotypal or antisocial personality disorder, and uncontrolled depression or suicidal ideation
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- change in antidepressant medications over the past 3 months
- women pregnant women, breast feeding, or planning on becoming pregnant
- currently enrolled in another research study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tailored Treatment to Enhance Risk Perception in Sleep Apnea.
Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious medical condition with significant medical and psychological consequences, including diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway creating a "pneumatic splint" to keep the airway open during sleep. Adherence to PAP is notoriously low, with as few as 50% reaching minimal guidelines for adherence. One comprehensive review of adherence research found that adherence to PAP was less than that for any other medical disorder. The problem of adherence is significant not only because of the medical consequences that can ensue, but also because third party payers have begun to refuse to pay for PAP therapy when adherence is less than optimal, even in the face of clinical improvement. This is a critical time to address this problem.
This research study is designed to identify methods that may help people respond to PAP, the most common therapy for OSA. Identifying these methods may be an important way to better care for patients with obstructive sleep apnea. With this research, the investigators hope to find ways to help people have a better response to treatment and a better quality of life.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- Brief Personalized Video (BPV), Non-Personalized Video (NPV), Treatment as Usual (TAU)
- 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.
Brief Personalized Video (BPV)Behavioural
Also called BPV
The BPV group will view a portion of their own sleep study that took place during their overnight sleep study.
Non-Personalized Video (NPV)Behavioural
Also called NPV
The NPV group will see a stock video of someone with OSA.
Treatment as Usual (TAU)Behavioural
Also called Standard of Care
The TAU group will not watch a video.
| Study group | Role | What they receive |
|---|---|---|
| Brief Personalized Video (BPV) | Experimental | Our BPV intervention focuses on augmenting risk perception and reducing optimistic bias by showing the patient a dramatic video of his/her own apnea (which shows them struggle to breathe), as well as by explaining the physiological processes involved in an apneic event. Specific apneic events are highlighted and associated decreases in blood oxygen levels are demonstrated via oxygen saturation recording superimposed on the video. This group will receive educational information about OSA, its consequences and the need for treatment. Receives: Behavioral: Brief Personalized Video (BPV) |
| Non-Personalized Video (NPV) | Active comparator | NPV will include a video of someone having apnea, but it will not be personalized. This group will receive educational information about OSA, its consequences and the need for treatment. Receives: Behavioral: Non-Personalized Video (NPV) |
| Treatment As Usual (TAU) | Placebo comparator | The TAU group will receive no special treatment from study interventionist team and will not view a video. Receives: Behavioral: Treatment as Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Adherence
Treatment adherence as measured directly from the participant's PAP device. Adherence is monitored objectively as time at prescribed pressure and daily measures of adherence are transmitted remotely to the study site nightly using a wireless modem. There are several specific adherence measures that will be available from the PAP units. These include the average hours of use per night across all nights, the average hours of use on nights PAP is actually used, and the percentage of nights PAP is used across all nights.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study start1 Oct 2014
- Primary completionApr 2020
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Mark Aloia, PhD, Principal investigator, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314858
- Sponsor's protocol ID
- 2809
- Other IDs
- R01HL120693
- Status last verified
- Jun 2021
- First submitted
- 8 Dec 2014
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailored Treatment to Enhance Risk Perception in Sleep Apnea.
- ClinicalTrials.gov ID
- NCT02314858
- Acronym / sponsor ID
- 2809
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- Apr 2020 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 11 Dec 2014 (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.
Obstructive Sleep Apnea (OSA) is seen in approximately 6% of Americans. It is a serious medical condition with significant medical and psychological consequences, including diabetes, hypertension, and cardiovascular disease. The treatment of choice for OSA is Positive Airway Pressure therapy (PAP). PAP supplies positive pressure to the upper airway creating a "pneumatic splint" to keep the airway open during sleep. Adherence to PAP is notoriously low, with as few as 50% reaching minimal guidelines for adherence. One comprehensive review of adherence research found that adherence to PAP was less than that for any other medical disorder. The problem of adherence is significant not only because of the medical consequences that can ensue, but also because third party payers have begun to refuse to pay for PAP therapy when adherence is less than optimal, even in the face of clinical improvement. This is a critical time to address this problem.
This research study is designed to identify methods that may help people respond to PAP, the most common therapy for OSA. Identifying these methods may be an important way to better care for patients with obstructive sleep apnea. With this research, the investigators hope to find ways to help people have a better response to treatment and a better quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Personalized Video (BPV) | Experimental | Behavioral: Brief Personalized Video (BPV)Our BPV intervention focuses on augmenting risk perception and reducing optimistic bias by showing the patient a dramatic video of his/her own apnea (which shows them struggle to breathe), as well as by explaining the physiological processes involved in an apneic event. Specific apneic events are highlighted and associated decreases in blood oxygen levels are demonstrated via oxygen saturation recording superimposed on the video. This group will receive educational information about OSA, its consequences and the need for treatment. |
| Non-Personalized Video (NPV) | Active comparator | Behavioral: Non-Personalized Video (NPV)NPV will include a video of someone having apnea, but it will not be personalized. This group will receive educational information about OSA, its consequences and the need for treatment. |
| Treatment As Usual (TAU) | Placebo comparator | Behavioral: Treatment as Usual (TAU)The TAU group will receive no special treatment from study interventionist team and will not view a video. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Polysomnography (PSG) confirmed diagnosis of Obstructive Sleep Apnea (OSA)
- choice of PAP as preferred treatment
- judged by sleep physicians to be responders to PAP
- participants will be considered responders to PAP if they have an AHI of less than 5, do not snore, and have an arousal index of less than 10 when titrated to the proper pressure of PAP
Key exclusion criteria (9 listed)
- Apnea-Hypopnea Index (AHI) < 15 on the diagnostic PSG and no daytime functional symptoms or associated cardiovascular disease
- a sleep disorder other than OSA that causes arousals from sleep (e.g., periodic limb movements, restless legs syndrome, insomnia)
- a current substance abuse problem
- a serious sleep-disruptive medical condition (e.g., end stage renal failure, severe Chronic Obstructive Pulmonary Disease (COPD), severe asthma)
- significant global cognitive impairment
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 |
|---|---|---|
| Brief Personalized Video (BPV)Also: BPVThe BPV group will view a portion of their own sleep study that took place during their overnight sleep study. | Behavioural | Brief Personalized Video (BPV) |
| Non-Personalized Video (NPV)Also: NPVThe NPV group will see a stock video of someone with OSA. | Behavioural | Non-Personalized Video (NPV) |
| Treatment as Usual (TAU)Also: Standard of CareThe TAU group will not watch a video. | Behavioural | Treatment As Usual (TAU) |
Primary outcome
Treatment Adherence
Time frame: 90 days
Treatment adherence as measured directly from the participant's PAP device. Adherence is monitored objectively as time at prescribed pressure and daily measures of adherence are transmitted remotely to the study site nightly using a wireless modem. There are several specific adherence measures that will be available from the PAP units. These include the average hours of use per night across all nights, the average hours of use on nights PAP is actually used, and the percentage of nights PAP is used across all 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 30 Jun 2021.
Related trials for Obstructive Sleep Apnea (OSA)
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
Obstructive Sleep Apnea
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
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
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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.
Mark Aloia, PhD principal investigator
National Jewish Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Personalized Video (BPV), Non-Personalized Video (NPV) and Treatment as Usual (TAU) in people with Obstructive Sleep Apnea (OSA), run by National Jewish Health 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 9 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 30 Jun 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. Some participants in this study may receive a placebo. 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?
Treatment Adherence (time frame: 90 days). 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 30 Jun 2021.