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Combination Therapy to Treat Sleep Apnea

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
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 11, 2017
Last verified: January 2017
Results First Received: January 13, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Participant);   Primary Purpose: Basic Science
Condition: Sleep Apnea, Obstructive
Interventions: Drug: Placebo pill
Drug: Sedative
Other: Room air
Other: Oxygen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with a previous diagnosis of OSA (defined as an apnoea/hypopnoea index [AHI] >10/hr) were recruited from the sleep clinic and Brigham and Women's Hospital and the general community (Boston, MA). The first patient was recruited in September 2012 and the last patient enrolled in May 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo and Air First, Then Eszopiclone and Oxygen Subjects will receive both a sugar pill and room air during two overnight sleep studies first and subsequently eszopiclone 3 mg with oxygen (FiO2 0.4) after a washout period of 1 week.
Eszopiclone and Oxygen First, Then Placebo and Air Subjects will receive both eszopiclone and medical grade oxygen (FIO2 0.4) during two overnight sleep studies, after a washout period of 1 week they will receive placebo and air during two overnight sleep studies

Participant Flow for 3 periods

Period 1:   First Intervention
    Placebo and Air First, Then Eszopiclone and Oxygen   Eszopiclone and Oxygen First, Then Placebo and Air
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 

Period 2:   Washout Period
    Placebo and Air First, Then Eszopiclone and Oxygen   Eszopiclone and Oxygen First, Then Placebo and Air
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 

Period 3:   Second Intervention
    Placebo and Air First, Then Eszopiclone and Oxygen   Eszopiclone and Oxygen First, Then Placebo and Air
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnoea; both were excluded from the analysis.

Reporting Groups
  Description
Study Group

This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions.

During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject demographics for the 20 remaining unselected patients are shown below.


Baseline Measures
   Study Group 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.9  (11.8) 
Gender 
[Units: Participants]
Count of Participants
 
Female      8  40.0% 
Male      12  60.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      20 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      1   5.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      7  35.0% 
White      12  60.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   20 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Model Prediction of Absence/Presence of OSA: Ventilation That Causes an Arousal From Sleep (Varousal)   [ Time Frame: Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2) ]

2.  Primary:   Model Prediction of Absence/Presence of OSA: Ventilatory Control Sensitivity (Loop Gain)   [ Time Frame: Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2) ]

3.  Primary:   Model Prediction of Absence/Presence of OSA: Passive Collapsibility   [ Time Frame: Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2) ]

4.  Primary:   Model Prediction of Absence/Presence of OSA: Active Collapsibility (Vactive)   [ Time Frame: Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2) ]

5.  Secondary:   Apnea-Hypopnea Index   [ Time Frame: Subjects will be assessed on day 1 (visit 1) and up to 1 month (visit 2) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The overall limitation is that we have only assessed the impact of combination therapy on one night. Thus, longitudinal studies will be needed to determine if the treatments remain effective.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Andrew Wellman
Organization: Brigham and Women's Hospital
phone: 617-732-8483
e-mail: awellman@rics.bwh.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: David Andrew Wellman, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01633827     History of Changes
Other Study ID Numbers: BWH-2012P000956
5R01HL102321-02 ( US NIH Grant/Contract Award Number )
Study First Received: June 25, 2012
Results First Received: January 13, 2016
Last Updated: January 11, 2017