Sleep Disordered BreathingNCT03927547
Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
A study testing Inclined Sleep in people with Sleep Disordered Breathing and Sleep Apnea, run by Johns Hopkins University at 1 site in Peru.
Trial summary
Overall objective: To understand the feasibility of performing a randomized trial using a simple, minimally-invasive postural therapy approach to improve sleep disordered breathing (SDB). Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disordered Breathing, Sleep Apnea
- What is being tested?
- Inclined Sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePeru
- Study dates
- 29 Sep 2019to 15 Mar 2020
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-80 years
- Daytime oxyhemoglobin saturation ≥80%, seated.
- Body mass index ≥25 kg/m2
- Hemoglobin >13 g/dL in women and >15 g/dL in men
- Ability to provide informed consent
- Sleeps at home in same bed every night
Show all 10Show fewer
- Expected stable residence for at least 6 months
- Sleeps with two pillows or fewer
- Demonstrate acute improvement in SDB severity with postural therapy
- Able to sleep ≥5 hours at an incline for all three nights during the run-in period
Who cannot join
- Works the night-shift or a rotating shift
- Has an indication or preference for sleeping upright, semi-recumbent or at an incline
- Chronic insomnia or a non-respiratory sleep disorder
- Physician-established diagnosis of diabetes, lung, cardiovascular, liver, or chronic kidney disease
- Using home oxygen therapy or other respiratory assistive device [e.g., continuous positive airway pressure (CPAP), nebulizer]
- Self-reported severe gastrointestinal reflux
Show all 14Show fewer
- Self-report of occult blood or history of gastrointestinal bleeding in the past 3 months
- Pregnancy
- Unable to sleep ≥5 hours at an incline for all three nights during the run-in period
- The following exclusion criteria apply only for those undergoing spirometry for safety reasons. Participants with any one of these criteria, will be excluded from spirometry but can still participate in the rest of the screening phase:
- Surgery of the heart, chest, lungs in the past 3 months (participants will be revisited at a later period)
- Heart attack in the past 3 months (participants will be revisited at a later period)
- History of eye surgery
- History of abdominal surgery in the past 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Overall objective: To understand the feasibility of performing a randomized trial using a simple, minimally-invasive postural therapy approach to improve sleep disordered breathing (SDB).
Read the detailed description
Specific Aims:
- To examine the relative efficacy of postural therapy (a 15-degree wedge mattress) on measures of chronic cardiometabolic stress in high altitude residents.
- To determine the tolerability of postural therapy.
Primary outcomes, at 4 and 8 weeks:
- Mean nocturnal oxyhemoglobin saturation (SPO2)
- Apnea-hypopnea index (AHI).
Secondary outcomes
- Markers of hypoxemia exposure: the investigators will evaluate for differences in average hemoglobin and erythropoietin concentrations between intervention groups using t-tests or Wilcoxon rank sum tests, as considered appropriate. If transformations are necessary, the investigators will use Box-Cox power transform to identify the best transformation for the investigators' data.
- Markers of metabolic dysfunction: the investigators will evaluate for differences in average Glycated hemoglobin test (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), total cholesterol, low-density lipoprotein cholesterol (LDL), High-density lipoprotein cholesterol (HDL), triglycerides, SVEGF-R1 , and soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations between intervention groups using t-tests or Wilcoxon rank sum tests, as appropriate. If transformations are necessary, the investigators will use Box-Cox power transform to identify the best transformation for the investigators' data.
- Markers of cardiometabolic stress: the investigators will evaluate for differences in average systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse, and % change in endothelial function (reactive hyperemia index) as assessed by brachial artery reactivity testing (BART) between intervention groups using t-tests or Wilcoxon rank sum tests, as considered appropriate.
- Adherence (the average number of nights during the 8-week period that participants slept on the wedge mattress),
- Conditions
- Sleep Disordered Breathing, Sleep Apnea
- Being tested
- Inclined Sleep
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclined SleepDevice
Also called wedge mattress, postural therapy
Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.
| Study group | Role | What they receive |
|---|---|---|
| Inclined Sleep | Experimental | Inclined mattress at 15 degrees Receives: Device: Inclined Sleep |
| Flat Sleep | No intervention | Plane mattress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respiratory Disturbance Index (RDI)
The investigators will measure a change in Respiratory Disturbance Index (RDI) defined as an oxygen desaturation of at least 4 percent associated with autonomic signs of arousal. Specifically, autonomic arousals are defined as concurrent rises in heart rate and attenuation of arterial tonometry.
Normal < 5 percent 5 percent < Mild < 15 percent 15 percent < Moderate < 30 percent Severe > 30 percent
Measured: Baseline, 4 weeks, 8 weeks
Change in Mean oxyhemoglobin saturation (percent) during sleep
The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8.
Measured: Baseline, 4 weeks, 8 weeks
Secondary outcomes (13)
Tolerability of postural therapy as assessed by adherence monitor
Adherence monitor will measure sleep over the set time points and tolerability is defined as a recorded time on the wedge for a minimum of 5 hours.
Measured: 2, 4, 6 and 8 weeks
Change in average plasma hemoglobin concentration (g/dL)
Measured: Baseline, 8 weeks
Change in average Glycated hemoglobin test (HbA1c)
This will measure percentage (%) of HbA1c in the blood.
Measured: Baseline, 8 weeks
Change in serum erythropoietin (EPO) concentration
The concentration of EPO in the sample is expressed in International Units per litre (U/L) and is determined by calibration against a reference standard.
Measured: Baseline, 8 weeks
Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations
Plasma levels of SVEGF-1 (pg/mL)
Measured: Baseline, 8 weeks
Change in homeostatic model assessment of insulin resistance (HOMA-IR)
Units of measurement is mass units.
Measured: Baseline, 8 weeks
Change in total plasma cholesterol level (mg/dL)
Measured: Baseline, 8 weeks
Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL)
Measured: Baseline, 8 weeks
Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL)
Measured: Baseline, 8 weeks
Change in plasma triglyceride concentration (mg/dL)
Measured: Baseline, 8 weeks
Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration
Units of measurement pg/mL
Measured: Baseline, 8 weeks
Change in mean blood pressure (mmHg)
Measured: Baseline, 8 weeks
Change in Brachial Artery Reactivity Testing (BART) assessment
Assessed by endothelial function using high-frequency ultrasound visualized brachial artery reactivity testing. Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest to the diameter after increased forearm blood flow (reactive hyperemia).
Unit of measurement is mass units.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start29 Sep 2019
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Disordered BreathingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William Checkley, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927547
- Sponsor's protocol ID
- IRB00170895
- Other IDs
- R34HL135360
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disordered Breathing and Cardiopulmonary Disease in Peruvian Highlanders
- ClinicalTrials.gov ID
- NCT03927547
- Acronym / sponsor ID
- IRB00170895
- Conditions
- Sleep Disordered Breathing, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 25 Apr 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.
Overall objective: To understand the feasibility of performing a randomized trial using a simple, minimally-invasive postural therapy approach to improve sleep disordered breathing (SDB).
Detailed description
Specific Aims:
- To examine the relative efficacy of postural therapy (a 15-degree wedge mattress) on measures of chronic cardiometabolic stress in high altitude residents.
- To determine the tolerability of postural therapy.
Primary outcomes, at 4 and 8 weeks:
- Mean nocturnal oxyhemoglobin saturation (SPO2)
- Apnea-hypopnea index (AHI).
Secondary outcomes
- Markers of hypoxemia exposure: the investigators will evaluate for differences in average hemoglobin and erythropoietin concentrations between intervention groups using t-tests or Wilcoxon rank sum tests, as considered appropriate. If transformations are necessary, the investigators will use Box-Cox power transform to identify the best transformation for the investigators' data.
- Markers of metabolic dysfunction: the investigators will evaluate for differences in average Glycated hemoglobin test (HbA1c), homeostatic model assessment of insulin resistance (HOMA-IR), total cholesterol, low-density lipoprotein cholesterol (LDL), High-density lipoprotein cholesterol (HDL), triglycerides, SVEGF-R1 , and soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations between intervention groups using t-tests or Wilcoxon rank sum tests, as appropriate. If transformations are necessary, the investigators will use Box-Cox power transform to identify the best transformation for the investigators' data.
- Markers of cardiometabolic stress: the investigators will evaluate for differences in average systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse, and % change in endothelial function (reactive hyperemia index) as assessed by brachial artery reactivity testing (BART) between intervention groups using t-tests or Wilcoxon rank sum tests, as considered appropriate.
- Adherence (the average number of nights during the 8-week period that participants slept on the wedge mattress),
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inclined Sleep | Experimental | Device: Inclined SleepInclined mattress at 15 degrees |
| Flat Sleep | No intervention | –Plane mattress |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 40-80 years
- Daytime oxyhemoglobin saturation ≥80%, seated.
- Body mass index ≥25 kg/m2
- Hemoglobin >13 g/dL in women and >15 g/dL in men
- Ability to provide informed consent
Key exclusion criteria (14 listed)
- Works the night-shift or a rotating shift
- Has an indication or preference for sleeping upright, semi-recumbent or at an incline
- Chronic insomnia or a non-respiratory sleep disorder
- Physician-established diagnosis of diabetes, lung, cardiovascular, liver, or chronic kidney disease
- Using home oxygen therapy or other respiratory assistive device [e.g., continuous positive airway pressure (CPAP), nebulizer]
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 |
|---|---|---|
| Inclined SleepAlso: wedge mattress, postural therapyStudy participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress. | Device | Inclined Sleep |
Primary outcome
Change in Respiratory Disturbance Index (RDI)
Time frame: Baseline, 4 weeks, 8 weeks
The investigators will measure a change in Respiratory Disturbance Index (RDI) defined as an oxygen desaturation of at least 4 percent associated with autonomic signs of arousal. Specifically, autonomic arousals are defined as concurrent rises in heart rate and attenuation of arterial tonometry. Normal < 5 percent 5 percent < Mild < 15 percent 15 percent < Moderate < 30 percent Severe > 30 percent
Change in Mean oxyhemoglobin saturation (percent) during sleep
Time frame: Baseline, 4 weeks, 8 weeks
The investigators will measure mean oxyhemoglobin saturation (%SaO2) during sleep as assessed by WatchPAT home sleep study at baseline and week 8.
13 secondary outcomes
Tolerability of postural therapy as assessed by adherence monitor
Time frame: 2, 4, 6 and 8 weeks
Change in average plasma hemoglobin concentration (g/dL)
Time frame: Baseline, 8 weeks
Change in average Glycated hemoglobin test (HbA1c)
Time frame: Baseline, 8 weeks
Change in serum erythropoietin (EPO) concentration
Time frame: Baseline, 8 weeks
Change in soluble Vascular Endothelial Growth Factor (SVEGF-1) concentrations
Time frame: Baseline, 8 weeks
Change in homeostatic model assessment of insulin resistance (HOMA-IR)
Time frame: Baseline, 8 weeks
Change in total plasma cholesterol level (mg/dL)
Time frame: Baseline, 8 weeks
Change in plasma low-density lipoprotein (LDL) cholesterol level (mg/dL)
Time frame: Baseline, 8 weeks
Change in plasma high-density lipoprotein (HDL) cholesterol level (mg/dL)
Time frame: Baseline, 8 weeks
Change in plasma triglyceride concentration (mg/dL)
Time frame: Baseline, 8 weeks
Change in Vascular endothelial growth factor receptor 1 (SVEGF-R1) concentration
Time frame: Baseline, 8 weeks
Change in mean blood pressure (mmHg)
Time frame: Baseline, 8 weeks
Change in Brachial Artery Reactivity Testing (BART) assessment
Time frame: Baseline, 8 weeks
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 6 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
William Checkley 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 Inclined Sleep in people with Sleep Disordered Breathing and Sleep Apnea, run by Johns Hopkins University at 1 site in Peru.
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 10 inclusion and 14 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 6 Nov 2020. 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 Peru. 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 Respiratory Disturbance Index (RDI) (time frame: Baseline, 4 weeks, 8 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 6 Nov 2020.