Combination Therapy to Treat Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Brigham and Women's Hospital
Sponsor:
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: January 29, 2014
Last verified: January 2014
  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 Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: January 29, 2014
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 July 22, 2014