Combination Therapy to Treat Sleep Apnea
This study is currently recruiting participants.
Verified March 2013 by Brigham and Women's Hospital
Sponsor:
Brigham and Women's Hospital
Collaborator:
Information provided by (Responsible Party):
David Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01633827
First received: June 25, 2012
Last updated: March 16, 2013
Last verified: March 2013
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Purpose
In Obstructive sleep apnea (OSA), the upper airway closes over and over again during sleep. This leads to disrupted sleep (waking up during the night), daytime sleepiness, and an increased risk for developing high blood pressure. Currently, the best treatment for obstructive sleep apnea is sleeping with a mask that continuously blows air into the nose (i.e. Continuous positive airway pressure [CPAP] treatment). While CPAP treatment stops the upper airway from closing in most people, many people have difficulty sleeping with the mask in place and therefore do not use the CPAP treatment. This research study is being conducted to learn whether using a combination of therapies (i.e. a sedative and oxygen therapy) will improve OSA severity by altering some of the traits that are responsible for the disorder.
| Condition | Intervention |
|---|---|
|
Sleep Apnea, Obstructive |
Drug: Placebo pill Drug: Sedative Other: Room air Other: Oxygen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Combination Therapy for the Treatment of Obstructive Sleep Apnea |
Resource links provided by NLM:
Further study details as provided by Brigham and Women's Hospital:
Primary Outcome Measures:
- Model prediction of absence/presence of OSA [ Time Frame: Subjects will be assessed on day 1 (visit 1) ] [ Designated as safety issue: No ]Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. These variables are measured using a single maneuver in which CPAP is dropped from an optimum to various suboptimum pressures during sleep. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.
- Model prediction of absence/presence of OSA [ Time Frame: Subjects will be assessed up to 1 month (visit 2) ] [ Designated as safety issue: No ]Our published method estimates 4 important physiological traits causing OSA: 1) pharyngeal anatomy, 2) loop gain, 3) the ability of the upper airway to dilate/stiffen in response to increases in ventilatory drive, and 4) arousal threshold. These variables are measured using a single maneuver in which CPAP is dropped from an optimum to various suboptimum pressures during sleep. Each individual's set of traits is then entered into a physiological model of OSA that graphically illustrates the relative importance of each trait in that individual and predicts OSA presence/absence.
Secondary Outcome Measures:
- Apnea-Hypopnea Index [ Time Frame: Subjects will be assessed on day 1 (visit 1) ] [ Designated as safety issue: No ]The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).
- Apnea-Hypopnea Index [ Time Frame: Subjects will be assessed up to 1 month (visit 2) ] [ Designated as safety issue: No ]The Apnea-Hypopnea Index (AHI) is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2012 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo
Subjects will receive both a sugar pill and room air during their overnight sleep studies
|
Drug: Placebo pill
Subjects will receive a sugar pill (in combination with room air) during their placebo arm studies
Other Name: sugar pill
Other: Room air
Subjects will receive room air (in combination with a sugar pill) during their placebo arm studies
|
|
Active Comparator: Treatment
Subjects will receive both Lunesta (eszopiclone) and medical grade oxygen during their overnight sleep studies
|
Drug: Sedative
Subjects will receive eszopiclone (in combination with medical oxygen) during their treatment arm studies
Other Name: Lunesta
Other: Oxygen
Subjects will receive medical grade oxygen (in combination with eszopiclone) during their treatment arm studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ages 18 - 79 years
- Documented OSA (AHI > 10 events/hr Non rapid eye movement sleep supine)
- If treated then, current CPAP use (>4 hrs CPAP/night for > 2 months)
Exclusion Criteria:
- Any uncontrolled medical condition
- Any other sleep disorder (Periodic leg movement syndrome, restless legs syndrome, insomnia, etc.)
- Use of medications known to affect sleep/arousal, breathing, or muscle physiology
- Allergy to lidocaine or Afrin
- Claustrophobia
- Alcohol consumption within 24 hours of PSG
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633827
Contacts
| Contact: Bradley A Edwards, PhD | 6177328456 | baedwards@partners.org |
| Contact: Lauren B Hess, BS | 6177328976 | lhess1@partners.org |
Locations
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Sub-Investigator: Bradley A Edwards, PhD | |
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
| Principal Investigator: | David A Wellman, MD | Brigham & Womens Hospital |
More Information
No publications provided
| Responsible Party: | David Andrew Wellman, Principal Investigator, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT01633827 History of Changes |
| Other Study ID Numbers: | BWH-2012P000956, 5R01HL102321-02 |
| Study First Received: | June 25, 2012 |
| Last Updated: | March 16, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
Contraceptives, Oral Hypnotics and Sedatives Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Central Nervous System Depressants Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013