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Sleep Specialty Consultation: Improving Management of Sleep Disorders

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00390572
First received: October 18, 2006
Last updated: April 6, 2015
Last verified: August 2014
Results First Received: September 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Sleep Disorders
Intervention: Behavioral: Sleep Specialty Consultation

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 156 subjects were consented and enrolled in the study, but 15 were excluded before randomization for not meeting entry criteria and 4 withdrew because they found study procedures too demanding. The remaining 137 continued in the study and were randomly assigned.

Reporting Groups
  Description
Sleep Specialty Consultation

Participants randomized to receive a one-time sleep consultation at beginning of study

Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers.

Treatment as Usual Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).

Participant Flow:   Overall Study
    Sleep Specialty Consultation   Treatment as Usual
STARTED   68   69 
COMPLETED   60   64 
NOT COMPLETED   8   5 
Lost to Follow-up                8                4 
health condition                0                1 



  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.
Intent to Treat: All participants who were randomized to treatment condition.

Reporting Groups
  Description
Sleep Specialty Consultation

Participants randomized to receive a one-time sleep consultation at beginning of study

Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers.

Treatment as Usual Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Total Total of all reporting groups

Baseline Measures
   Sleep Specialty Consultation   Treatment as Usual   Total 
Overall Participants Analyzed 
[Units: Participants]
 68   69   137 
Age 
[Units: Years]
Mean (Standard Deviation)
 55.0  (13.7)   55.9  (13.4)   55.4  (13.5) 
Gender 
[Units: Participants]
     
Female   14   15   29 
Male   54   54   108 
Region of Enrollment 
[Units: Participants]
     
United States   68   69   137 


  Outcome Measures
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1.  Primary:   Provider Adherence to Sleep Specialist Recommendations   [ Time Frame: 10 months after baseline ]

2.  Primary:   Diary Sleep: Total Wake Time and Total Sleep Time   [ Time Frame: 10 months ]

3.  Primary:   Sleep Efficiency   [ Time Frame: 10 Months after Baseline ]

4.  Primary:   Sleep Quality   [ Time Frame: 10 Months ]

5.  Secondary:   Sleepiness   [ Time Frame: 10 months ]


  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
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  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: Christi S. Ulmer, PhD
Organization: VA HSRD
phone: 9192860411 ext 4044
e-mail: christi.ulmer@va.gov


Publications of Results:
Edinger JD, Ulmer CS, Grubber J, Zervakis JB, Olsen MK. Effects of a One-Time Sleep Specialty Consultation on Sleep Problem Management in Primary Care. [Abstract]. Sleep. 2011 Oct 20; 34(Suppl):A337,0984.
Zervakis JB, Ulmer CS, Edinger JD. Can a One-Time Sleep Specialty Consultation Enhance Providers' Attention to Sleep Problems in Primary Care? [Abstract]. Sleep. 2010 Mar 1; 33(Suppl):A365,1092.

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

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00390572     History of Changes
Other Study ID Numbers: IIR 05-213
0016 ( Other Grant/Funding Number: VA R&D )
01147 ( Other Grant/Funding Number: VA R&D )
Study First Received: October 18, 2006
Results First Received: September 9, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government