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A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT01569022
Recruitment Status : Completed
First Posted : April 2, 2012
Results First Posted : November 8, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Obstructive Sleep Apnea
Interventions: Device: CPAP
Device: MAD

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 127 Veterans were considered for study participation between August 2013 and April 2016. Fifty-four patients agreed to enroll in the study but twelve patients either failed to return for scheduled visits or withdrew from further participation because of lack of time or other pressing matters. Forty-two were randomized to CPAP or MAD.

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
CPAP First, MAD

CPAP treatment for sleep apnea

CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks

MAD First, CPAP

MAD treatment for sleep apnea

MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks


Participant Flow for 2 periods

Period 1:   First Intervention
    CPAP First, MAD   MAD First, CPAP
STARTED   21   21 
COMPLETED   19   20 
NOT COMPLETED   2   1 
Lost to Follow-up                2                1 

Period 2:   Second Intervention
    CPAP First, MAD   MAD First, CPAP
STARTED   19   20 
COMPLETED   17   18 
NOT COMPLETED   2   2 
Lost to Follow-up                2                2 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
All Study Participants

Participants were asked to acclimate to CPAP and MAD for 4 weeks (total) during which adjustments to both modes of therapy are made aiming to optimize comfort and abolish snoring.

If the interface was found to be uncomfortable, the patient was given the opportunity to change the mask. None of the participants was exposed to dual therapy or had access to both devices at the same time. Weekly phone calls were made to inquire about side effects or problems with CPAP or MAD. At the end of the acclimatization period, patients underwent a 2-week washout, after which they were randomly assigned in 1:1 ratio via a presealed and numbered opaque white envelope to one of the two treatment modalities (CPAP or MAD) that included the assignment to receive 12 weeks of treatment with MAD and CPAP in alternating order


Baseline Measures
   All Study Participants 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.7  (11.6) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      5  14.3% 
Male      30  85.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      5  14.3% 
White      30  85.7% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Residual Apnea Hypopnea Index   [ Time Frame: up to 12 weeks ]

2.  Secondary:   Health Outcomes   [ Time Frame: 12 weeks ]

3.  Secondary:   General Health SF-36   [ Time Frame: 12 weeks ]

4.  Secondary:   Adherence to Therapy   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ali El Solh
Organization: VA Western New York
phone: 716-862-6525
e-mail: ali.el-solh@va.gov


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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01569022     History of Changes
Other Study ID Numbers: CLIN-005-11F
First Submitted: March 20, 2012
First Posted: April 2, 2012
Results First Submitted: August 25, 2017
Results First Posted: November 8, 2017
Last Update Posted: November 8, 2017