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Do Endotypes Predict Response and Sequelae in OSA Patients (ExPRESSION)

Primary Purpose

Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea, Obstructive

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Supplemental Oxygen
Continuous Positive Airway Pressure (CPAP)
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring sleep, sleep apnea, OSA, obstructive sleep apnea, lunesta, cpap, endotype, Eszopiclone

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 21-65 years old
  • Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - * see below)
  • BMI 20 - 35 kg/m2

Exclusion Criteria:

  • Pregnancy (current or planned)
  • Nursing
  • Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English.
  • Already on effective therapy and adherent to treatment for OSA
  • Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy
  • Circadian rhythm disorder
  • Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure
  • Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >95)
  • Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.
  • Presence of tracheostomy
  • Hospitalization within the past 90 days
  • Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (< 5 years)
  • Prior gastric bypass surgery
  • Chronic liver disease or end-stage kidney disease
  • Active cancer
  • Allergy to any of the study drug
  • Regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline)
  • Chronically using study drug (Eszopiclone)
  • Active illicit substance use
  • Alcohol use of >1 standard drink/night for women or >2 standard drinks/night for men nightly alcohol use
  • Active smoking or vaping within the past 6 months
  • Psychiatric disease, other than controlled depression/anxiety

  • Prisoners

    • Subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (HSAT) to verify OSA diagnosis.

Sites / Locations

  • Altman Clinical and Translational Research Institute BuildingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early PAP Start

Usual PAP Start

Arm Description

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.

After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).

Outcomes

Primary Outcome Measures

Psychomotor Vigilance Test
A 10-minutes, computerized reaction test asking subject to press a button every time a prompt appears. Faster times indicate better reactions and higher alertness.
Endothelial Dysfunction
Using a device called EndoPAT for a non-invasive bloodflow measure before, during, and after 5-minutes of occlusion to one arm. Differences in EndoPAT results will be compared between treatments.

Secondary Outcome Measures

Neurocognitive Assessment: NIH Toolbox
This battery yields three composite scores: overall cognitive function, crystallized cognition and fluid cognition. The two tests of "crystallized cognition" are less sensitive to acquired brain dysfunction and reflect past learning experiences (Oral Reading Recognition and Picture Vocabulary). The five tests of "fluid cognition" assess multiple cognitive domains that are vulnerable to acquired brain dysfunction (i.e., Picture Sequence Memory Task = episodic memory, Dimensional Change Card Sort Task = executive function/flexibility, Pattern Comparison Task = processing speed, Flanker Inhibitory Control and Attention Task = executive function/inhibitory control, and List Sorting Task = working memory).
Epworth Sleepiness Scale (ESS)
A self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Pittsburgh Sleep Quality Index (PSQI)
A 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Insomnia Severity Index (ISI)
A 7-item self-report form to assess insomnia severity. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
Richard's Campbell Sleep Questionnaire (RCSQ)
A five-item self-report questionnaire that is used in order to assess perceived sleep depth, sleep latency (time to fall asleep), and number of awakenings, as well as sleep efficiency and quality. Each item is scored on a visual analog scale ranging from 0 mm to 100 mm, with higher scores representing better sleep. The mean score of the five items is known as the total score and represents the overall perception of sleep.
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
A 40-item questionnaire to assesses self-reported fatigue and its impact upon daily activities and function. The score ranges from 0 to 160 with greater values indicating better quality of life.
Beck Depression Index-II
The questionnaire assesses mental health (i.e. depression). Each of the 21 items are given weighted values corresponding to a symptom of depression and summed to give a single score. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
SF-36 Item Health Survey (SF-36)
A set of 36 generic, coherent, and easily administered quality-of-life measures. Scoring consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Brief Pain Inventory (Short Form)
A 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale with 10 being the most pain.
PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity
A self-reported form to assess how much pain a person is feeling.
Systolic Blood Pressure
Measured at rest following standard guidelines.
Diastolic Blood Pressure
Measured at rest following standard guidelines.
Patient's Assessment of Own Function Inventory (PAOF) questionnaire
A subjective measure of cognitive function that asks participants to rate how often they experience difficulty in four areas: memory, language/communication, sensory-motor ability, and executive function with response options from 0 ("almost never") to 5 ("almost always").
PROMIS (Patient-Reported Outcomes Measurement Information System) pain interference
A self-reported measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.

Full Information

First Posted
April 27, 2021
Last Updated
August 2, 2023
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04875364
Brief Title
Do Endotypes Predict Response and Sequelae in OSA Patients
Acronym
ExPRESSION
Official Title
Do Endotypes Predict Response and Sequelae in OSA Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 1, 2027 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea, Obstructive, Sleep, Sleep Disorder
Keywords
sleep, sleep apnea, OSA, obstructive sleep apnea, lunesta, cpap, endotype, Eszopiclone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early PAP Start
Arm Type
Experimental
Arm Description
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will be set up with a loaner CPAP for 8 weeks to initiate therapy right away.
Arm Title
Usual PAP Start
Arm Type
Experimental
Arm Description
After two initial baseline overnight studies, and two experimental overnight studies during which subjects will receive Eszopiclone (2mg before bedtime) or oxygen (4L/min via nasal cannula for the duration of the time in bed) in random order, subjects will remain untreated until they are set up with their clinically prescribed CPAP (typically takes about 8 weeks).
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Other Intervention Name(s)
Lunesta
Intervention Description
2mg of Eszopiclone just before going to sleep.
Intervention Type
Other
Intervention Name(s)
Supplemental Oxygen
Intervention Description
Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
A standard CPAP device will be provided using the settings as prescribed by the treating physician.
Primary Outcome Measure Information:
Title
Psychomotor Vigilance Test
Description
A 10-minutes, computerized reaction test asking subject to press a button every time a prompt appears. Faster times indicate better reactions and higher alertness.
Time Frame
8 weeks
Title
Endothelial Dysfunction
Description
Using a device called EndoPAT for a non-invasive bloodflow measure before, during, and after 5-minutes of occlusion to one arm. Differences in EndoPAT results will be compared between treatments.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Neurocognitive Assessment: NIH Toolbox
Description
This battery yields three composite scores: overall cognitive function, crystallized cognition and fluid cognition. The two tests of "crystallized cognition" are less sensitive to acquired brain dysfunction and reflect past learning experiences (Oral Reading Recognition and Picture Vocabulary). The five tests of "fluid cognition" assess multiple cognitive domains that are vulnerable to acquired brain dysfunction (i.e., Picture Sequence Memory Task = episodic memory, Dimensional Change Card Sort Task = executive function/flexibility, Pattern Comparison Task = processing speed, Flanker Inhibitory Control and Attention Task = executive function/inhibitory control, and List Sorting Task = working memory).
Time Frame
8 weeks
Title
Epworth Sleepiness Scale (ESS)
Description
A self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
Time Frame
8 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
A 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.
Time Frame
8 weeks
Title
Insomnia Severity Index (ISI)
Description
A 7-item self-report form to assess insomnia severity. Total score categories: 0-7 = No clinically significant insomnia, 8-14 = Subthreshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
Time Frame
8 weeks
Title
Richard's Campbell Sleep Questionnaire (RCSQ)
Description
A five-item self-report questionnaire that is used in order to assess perceived sleep depth, sleep latency (time to fall asleep), and number of awakenings, as well as sleep efficiency and quality. Each item is scored on a visual analog scale ranging from 0 mm to 100 mm, with higher scores representing better sleep. The mean score of the five items is known as the total score and represents the overall perception of sleep.
Time Frame
8 weeks
Title
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
Description
A 40-item questionnaire to assesses self-reported fatigue and its impact upon daily activities and function. The score ranges from 0 to 160 with greater values indicating better quality of life.
Time Frame
8 weeks
Title
Beck Depression Index-II
Description
The questionnaire assesses mental health (i.e. depression). Each of the 21 items are given weighted values corresponding to a symptom of depression and summed to give a single score. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time Frame
8 weeks
Title
SF-36 Item Health Survey (SF-36)
Description
A set of 36 generic, coherent, and easily administered quality-of-life measures. Scoring consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time Frame
8 weeks
Title
Brief Pain Inventory (Short Form)
Description
A 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale with 10 being the most pain.
Time Frame
8 weeks
Title
PROMIS (Patient-Reported Outcomes Measurement Information System) pain intensity
Description
A self-reported form to assess how much pain a person is feeling.
Time Frame
8 weeks
Title
Systolic Blood Pressure
Description
Measured at rest following standard guidelines.
Time Frame
8 weeks
Title
Diastolic Blood Pressure
Description
Measured at rest following standard guidelines.
Time Frame
8 weeks
Title
Patient's Assessment of Own Function Inventory (PAOF) questionnaire
Description
A subjective measure of cognitive function that asks participants to rate how often they experience difficulty in four areas: memory, language/communication, sensory-motor ability, and executive function with response options from 0 ("almost never") to 5 ("almost always").
Time Frame
8 weeks
Title
PROMIS (Patient-Reported Outcomes Measurement Information System) pain interference
Description
A self-reported measure the self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 21-65 years old Men and women with a physician diagnosis of OSA (or strongly suspected to have sleep apnea - * see below) BMI 20 - 35 kg/m2 Exclusion Criteria: Pregnancy (current or planned) Nursing Inability to provide self-consent or complete study procedures, such as questionnaires that are only available/validated in English. Already on effective therapy and adherent to treatment for OSA Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy Circadian rhythm disorder Unrevascularized coronary artery disease, angina, prior heart attack or stroke, congestive heart failure Uncontrolled hypertension (systolic blood pressure >160, diastolic blood pressure >95) Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease. Presence of tracheostomy Hospitalization within the past 90 days Prior peptic ulcer disease, esophageal varices, or gastrointestinal bleeding (< 5 years) Prior gastric bypass surgery Chronic liver disease or end-stage kidney disease Active cancer Allergy to any of the study drug Regular use of medications known to affect control of breathing (opioids, sedatives/hypnotics including benzodiazepines, theophylline) Chronically using study drug (Eszopiclone) Active illicit substance use Alcohol use of >1 standard drink/night for women or >2 standard drinks/night for men nightly alcohol use Active smoking or vaping within the past 6 months Psychiatric disease, other than controlled depression/anxiety Prisoners Subjects who are strongly suspected to have sleep apnea will be offered an overnight home sleep apnea test (HSAT) to verify OSA diagnosis.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela DeYoung
Phone
8582462154
Email
pdeyoung@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Malhotra, MD
Organizational Affiliation
Professor, Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher Schmickl
Organizational Affiliation
Postdoc Fellow, Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altman Clinical and Translational Research Institute Building
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela DeYoung
Phone
858-246-2154
Email
pdeyoung@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Dillon Gilbertson, MS
Phone
8582462154
Email
dcgilbertson@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Christopher Schmickl

12. IPD Sharing Statement

Learn more about this trial

Do Endotypes Predict Response and Sequelae in OSA Patients

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