Sleep ApneaPISANCT01578031

The Effects of Treating Obese and Lean Patients With Sleep Apnea

A study testing Positive Airway Pressure During Sleep (ResMed S9 Elite) in people with Sleep Apnea and Obesity, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Sleep Apnea, Obesity
What is being tested?: Positive Airway Pressure During Sleep (ResMed S9 Elite)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Sep 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age 40-65 years; Will only recruit post-menopausal women not on hormone replacement therapy to avoid the potential confounding effects of female hormones on OSA prevalence and severity, fat distribution as well as the end-points (50-60)
Lean subjects need to have a waist circumference score <= 107 cm in men and <= 96 cm in women.
Obese subjects need to have a waist circumference score > 107 cm in men and > 96 cm in women
For OSA volunteers, 15 ≤ AHI ≤ 75 (see Preliminary Results for justification of upper limit) on full-night in-laboratory polysomnogram within the last 6 months.
Stable medical history and no change in medications, including anti-hypertensive and lipid-lowering medications, in the previous 2 months
No regular daytime use (> 3 times/week) of sedative or hypnotic medications in the last 2 months
Arm circumference ≤ 50 cm (manufacturer limit for performing ambulatory BP recording)

Who cannot join

Unable or unwilling to provide informed consent.
Not satisfied with reimbursement
Time constraints
No telephone access or inability to return for follow up testing.
BMI > 40 kg/m2.
Diagnosis of another sleep disorder in addition to OSA based on PSG (e.g., periodic limb movement disorder [≥ 15 limb movements/hour of sleep with arousal], central sleep apnea [≥ 50% of apneas on diagnostic PSG are central apneas], insomnia, restless legs syndrome obesity hypoventilation syndrome, or narcolepsy).

Show all 21Show fewer

Previous treatment with positive airway pressure, home oxygen therapy, tracheotomy, uvulopalatopharyngoplasty, or other surgery for OSA
Requiring oxygen or bi-level positive airway pressure for treatment of OSA.
A clinically unstable medical condition as defined by a new diagnosis or change in medical management in the previous 2 months (e.g., myocardial infarction, congestive heart failure, Cheyne-Stokes breathing, unstable angina, thyroid disease, depression or psychosis, ventricular arrhythmias, cirrhosis, surgery, or recently diagnosed cancer)
Positive urine toxicology screen
Rotating Night shift workers in situations or occupations where they regularly experience jet lag, or have irregular work schedules by history over the last 6 months.
Routine consumption of more than 2 alcoholic beverages per day as determined by the CAGE questionnaire (63-65).
Unable to perform tests due to inability to communicate verbally, inability to write and read in English; less than a 5th grade reading level; visual, hearing or cognitive impairment (e.g. previous head injury); or upper extremity motor deficit (e.g., previous stroke that prevents patient from using CPAP treatment).
Current illicit drug use
Excessive caffeine use (More than 10 caffeinated beverages per day)
Recent or recurring history of recreational drug use leading to tolerance or dependance.
Subjects with known moderate to severe renal disease will not undergo the enhanced or dynamic portion of the study.
Women with a positive pregnancy test will be excluded from the study.
Subjects who are found to have mild sleep apnea will be ineligible to participate further in the study and will paid up until that time.
Active infection, malignancy or chronic inflammatory disorders such as autoimmune diseases since these conditions can alter inflammatory biomarker levels.
No metal parts in the body as participants would not be allowed to enter the magnet during their MRI

Trial locations and contacts

1 site in 1 country.

United States1 site

Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Responses to CPAP Treatment in Obese and Lean Sleep Apnea Patients

The investigators' overall goal is to compare the effect of CPAP treatment on intermediate cardiovascular risk measures in obese versus lean patients with obstructive sleep apnea (OSA). The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with comparable amounts of visceral adiposity, the two OSA groups will have comparable improvements in daytime sleepiness, but that the cardiovascular and metabolic improvements following CPAP therapy will be decreased in OSA patients with increased visceral adipose tissue. The investigators anticipate that, although there will be a greater absolute change in markers of sympathetic activity, inflammation and oxidative stress in obese compared to lean OSA patients following CPAP treatment, the levels will still be abnormally high in the obese patients resulting in the decreased improvements in insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients.

Read the detailed description

Obesity and obstructive sleep apnea (OSA) are independent risk factors for insulin resistance, systemic hypertension and cardiovascular disease. Both obesity and OSA are associated with increased sympathetic activity, inflammatory activity, and oxidative stress, the presumed mediators of their shared clinical consequences. Due to the conflicting results of previous intervention studies treating OSA patients with CPAP, the investigators still do not know if treatment of obese OSA patients has a substantial benefit on these risk factors. In Aim 1, to determine the effects of obesity on the response to CPAP treatment in OSA patients, the investigators will compare responses in daytime sleepiness, insulin resistance, and arterial blood pressure following CPAP treatment in obese and lean OSA patients, stratified by the amount of abdominal visceral adipose tissue, a fat depot associated with increased sympathetic activity, inflammation, and oxidative stress, and a more powerful predictor than BMI of adverse cardiovascular and metabolic outcomes. Aim 2 will determine the effect of CPAP treatment in these two patients groups on sympathetic activity, and inflammatory and oxidative stress biomarkers. The overall hypothesis is that, adjusting for OSA severity and obtaining normative data from non-OSA subjects with comparable amounts of visceral adiposity (Aim 3), the two OSA groups will have comparable improvements in daytime sleepiness, but that the cardiovascular and metabolic improvements following CPAP therapy will be decreased in OSA patients with increased visceral adipose tissue. The investigators anticipate that, although there will be a greater absolute change in markers of sympathetic activity, inflammation and oxidative stress in obese compared to lean OSA patients following CPAP treatment, the levels will still be abnormally high in the obese patients resulting in the decreased improvements in insulin resistance, arterial blood pressure, and vascular health in obese versus lean OSA patients. Relevance: Obese patients are at increased risk of developing sleep apnea. Both obesity and sleep apnea are felt to increase the risk of diabetes, hypertension, and cardiovascular disease. The proposed research will begin to determine if treating obese patients with sleep apnea helps to reduce these risks. If the beneficial effects of CPAP treatment are reduced in obese compared to lean patients with sleep apnea, then treatment of sleep apnea in obese patients needs to be combined with effective management of their obesity.

Conditions: Sleep Apnea, Obesity
Being tested: Positive Airway Pressure During Sleep (ResMed S9 Elite), Usual Care
Keywords: Sleep Apnea, Obesity
Medical subject headings: Sleep Apnea Syndromes, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive Airway Pressure During Sleep (ResMed S9 Elite)Device
Positive airway pressure during sleep (ResMed S9 Elite).
Usual CareOther
Usual care.

Study groups in NCT01578031
Study group	Role	What they receive
Obese Patients with Obstructive Sleep Apnea	Active comparator	Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment. Receives: Device: Positive Airway Pressure During Sleep (ResMed S9 Elite)
Non-obese Patients with Obstructive Sleep Apnea	Active comparator	Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment. Receives: Device: Positive Airway Pressure During Sleep (ResMed S9 Elite)
Obese subjects without OSA	Other	Control. Receives: Other: Usual Care
Non-obese subjects without OSA	Other	Control. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Mean Arterial Blood Pressure
Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment
Measured: 4 months

Secondary outcomes (4)

Change From Baseline in Psychomotor Vigilance Task
Change from Baseline in Psychomotor Vigilance Task as measured by number of lapses during 10-minute Reaction time test.
Measured: 4 months
Change From Baseline in Sympathetic Nervous System Activity
Change from Baseline in Sympathetic Nervous System Activity as measured by 24-hour urine collection for norepinephrine levels.
Measured: 4 months
Change From Baseline in Circulating Inflammatory Biomarker
Change from Baseline in Circulating Inflammatory Biomarker: IL-6.
Measured: 4 months
Change From Baseline in Oxidative Stress
Overnight urinary excretion of 8-isoprostane.
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Sep 2014

First posted16 Apr 2012 (estimated)
Study startMar 2009
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Sleep ApneaStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01578031
Sponsor's protocol ID: NIH P02 HL094307-01
Acronym: PISA
Status last verified: Jun 2019
First submitted: 11 Apr 2012
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Imayama I, Gupta A, Yen PS, Chen YF, Keenan B, Townsend RR, Chirinos JA, Weaver FM, Carley DW, Kuna ST, Prasad B. Socioeconomic status impacts blood pressure response to positive airway pressure treatment. J Clin Sleep Med. 2022 May 1;18(5):1287-1295. doi: 10.5664/jcsm.9844.
PubMed 34931603
Xu L, Keenan BT, Maislin D, Gislason T, Benediktsdottir B, Gudmundsdottir S, Gardarsdottir M, Staley B, Pack FM, Guo X, Feng Y, Chahwala J, Manaktala P, Hussein A, Reddy-Koppula M, Hashmath Z, Lee J, Townsend RR, Schwab RJ, Pack AI, Kuna ST, Chirinos JA. Effect of Obstructive Sleep Apnea and Positive Airway Pressure Therapy on Cardiac Remodeling as Assessed by Cardiac Biomarker and Magnetic Resonance Imaging in Nonobese and Obese Adults. Hypertension. 2021 Mar 3;77(3):980-992. doi: 10.1161/HYPERTENSIONAHA.120.15882. Epub 2021 Jan 19.
PubMed 33461313
Feng Y, Maislin D, Keenan BT, Gislason T, Arnardottir ES, Benediktsdottir B, Chirinos JA, Townsend RR, Staley B, Pack FM, Sifferman A, Pack AI, Kuna ST. Physical Activity Following Positive Airway Pressure Treatment in Adults With and Without Obesity and With Moderate-Severe Obstructive Sleep Apnea. J Clin Sleep Med. 2018 Oct 15;14(10):1705-1715. doi: 10.5664/jcsm.7378.
PubMed 30353806

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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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Comprehensive Opioid Management and Breathing During Sleep
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Recruiting
Janus II Feasibility
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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)
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All Sleep Apnea trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Responses to CPAP Treatment in Obese and Lean Sleep Apnea Patients
ClinicalTrials.gov ID: NCT01578031
Acronym / sponsor ID: PISA / NIH P02 HL094307-01
Conditions: Sleep Apnea, Obesity
Keywords: Sleep Apnea, Obesity
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: University of Iceland
Study start: Mar 2009
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 16 Apr 2012 (estimated)
Results: Posted 18 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Obese Patients with Obstructive Sleep Apnea	Active comparator	Device: Positive Airway Pressure During Sleep (ResMed S9 Elite)Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Non-obese Patients with Obstructive Sleep Apnea	Active comparator	Device: Positive Airway Pressure During Sleep (ResMed S9 Elite)Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.
Obese subjects without OSA	Other	Other: Usual CareControl.
Non-obese subjects without OSA	Other	Other: Usual CareControl.

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age 40-65 years; Will only recruit post-menopausal women not on hormone replacement therapy to avoid the potential confounding effects of female hormones on OSA prevalence and severity, fat distribution as well as the end-points (50-60)
Lean subjects need to have a waist circumference score <= 107 cm in men and <= 96 cm in women.
Obese subjects need to have a waist circumference score > 107 cm in men and > 96 cm in women
For OSA volunteers, 15 ≤ AHI ≤ 75 (see Preliminary Results for justification of upper limit) on full-night in-laboratory polysomnogram within the last 6 months.
Stable medical history and no change in medications, including anti-hypertensive and lipid-lowering medications, in the previous 2 months

Key exclusion criteria (21 listed)

Unable or unwilling to provide informed consent.
Not satisfied with reimbursement
Time constraints
No telephone access or inability to return for follow up testing.
BMI > 40 kg/m2.

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
Positive Airway Pressure During Sleep (ResMed S9 Elite)Positive airway pressure during sleep (ResMed S9 Elite).	Device	Non-obese Patients with Obstructive Sleep Apnea, Obese Patients with Obstructive Sleep Apnea
Usual CareUsual care.	Other	Non-obese subjects without OSA, Obese subjects without OSA

Primary outcome

Change From Baseline in Mean Arterial Blood Pressure
Time frame: 4 months
Change in mean 24-hour ambulatory blood pressure from baseline following 4-months of PAP treatment

4 secondary outcomes

Change From Baseline in Psychomotor Vigilance Task
Time frame: 4 months
Change From Baseline in Sympathetic Nervous System Activity
Time frame: 4 months
Change From Baseline in Circulating Inflammatory Biomarker
Time frame: 4 months
Change From Baseline in Oxidative Stress
Time frame: 4 months

Results and safety

Results posted to the registry on 18 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Obese Patients With Obstructive Sleep Apnea	129	67
Non-obese Patients With Obstructive Sleep Apnea	69	35
Obese Subjects Without OSA	12	12
Non-obese Subjects Without OSA	30	30

Primary outcome: Change From Baseline in Mean Arterial Blood Pressure

Time frame: 4 months. Mean (Inter-Quartile Range). Unit: mm Hg

Measure	Obese Patients With Obstructive Sleep Apnea n = 88	Non-obese Patients With Obstructive Sleep Apnea n = 46
Value	-4.21 (-7.12 to -1.29)	-0.95 (-4.02 to 2.12)

Population analysed: These numbers reflect the overall number of participants who completed 4 months of CPAP treatment (i.e., the completer's analysis) and have complete data for this outcome.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until completion of tests and procedures. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Obese Patients With Obstructive Sleep Apnea	5 of 129 (3.9%)	32 of 129 (24.8%)	1 of 129
Non-obese Patients With Obstructive Sleep Apnea	4 of 69 (5.8%)	7 of 69 (10.1%)	0 of 69
Obese Patients Without Sleep Apnea	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Non-obese Patients Without Sleep Apnea	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34931603Imayama I, Gupta A, Yen PS, Chen YF, Keenan B, Townsend RR, Chirinos JA, Weaver FM, Carley DW, Kuna ST, Prasad B. Socioeconomic status impacts blood pressure response to positive airway pressure treatment. J Clin Sleep Med. 2022 May 1;18(5):1287-1295. doi: 10.5664/jcsm.9844.
Derived from this study: PubMed 33461313Xu L, Keenan BT, Maislin D, Gislason T, Benediktsdottir B, Gudmundsdottir S, Gardarsdottir M, Staley B, Pack FM, Guo X, Feng Y, Chahwala J, Manaktala P, Hussein A, Reddy-Koppula M, Hashmath Z, Lee J, Townsend RR, Schwab RJ, Pack AI, Kuna ST, Chirinos JA. Effect of Obstructive Sleep Apnea and Positive Airway Pressure Therapy on Cardiac Remodeling as Assessed by Cardiac Biomarker and Magnetic Resonance Imaging in Nonobese and Obese Adults. Hypertension. 2021 Mar 3;77(3):980-992. doi: 10.1161/HYPERTENSIONAHA.120.15882. Epub 2021 Jan 19.
Derived from this study: PubMed 30353806Feng Y, Maislin D, Keenan BT, Gislason T, Arnardottir ES, Benediktsdottir B, Chirinos JA, Townsend RR, Staley B, Pack FM, Sifferman A, Pack AI, Kuna ST. Physical Activity Following Positive Airway Pressure Treatment in Adults With and Without Obesity and With Moderate-Severe Obstructive Sleep Apnea. J Clin Sleep Med. 2018 Oct 15;14(10):1705-1715. doi: 10.5664/jcsm.7378.

Related trials for Sleep Apnea

RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
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
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
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Recruiting
Janus II Feasibility
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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

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.

Samuel Kuna, MD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positive Airway Pressure During Sleep (ResMed S9 Elite) in people with Sleep Apnea and Obesity, run by University of Pennsylvania 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 7 inclusion and 21 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 5 Jul 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?

Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 From Baseline in Mean Arterial Blood Pressure (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01578031, which also lists 3 linked publications.

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 5 Jul 2019.