ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 39 of 2197 for:    Symptoms | Parasomnias

Sleep Specialty Consultation: Improving Management of Sleep Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00390572
Recruitment Status : Completed
First Posted : October 20, 2006
Results First Posted : November 5, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Sleep Disorders
Intervention Behavioral: Sleep Specialty Consultation
Enrollment 156

Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Period Title: Overall Study
Started 68 69
Completed 60 64
Not Completed 8 5
Reason Not Completed
Lost to Follow-up             8             4
health condition             0             1
Arm/Group Title Sleep Specialty Consultation Treatment as Usual Total
Hide Arm/Group Description

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period). Total of all reporting groups
Overall Number of Baseline Participants 68 69 137
Hide Baseline Analysis Population Description
Intent to Treat: All participants who were randomized to treatment condition.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 69 participants 137 participants
55.0  (13.7) 55.9  (13.4) 55.4  (13.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 69 participants 137 participants
Female
14
  20.6%
15
  21.7%
29
  21.2%
Male
54
  79.4%
54
  78.3%
108
  78.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 69 participants 137 participants
68 69 137
1.Primary Outcome
Title Provider Adherence to Sleep Specialist Recommendations
Hide Description Provider outcomes included the provider’s number of participant sleep lab referrals, referrals to other specialty clinics for evaluation/treatment participant sleep problems, and presence of newly initiated sleep-focused therapies for participants. Information about these outcomes was obtained via review of provider orders and information included in notes entered into the VA’s computerized medical record system (CPRS). To quantify this outcome, the number of participants referred by providers for sleep-focused diagnostic tests and interventions was compared across arms.
Time Frame 10 months after baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was included for all participants.
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description:

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Overall Number of Participants Analyzed 68 69
Measure Type: Number
Unit of Measure: participants
Ferritin Level Check Ordered 4 0
Sleep Clinic Referral 8 4
Polysomnography Referral for Apnea 32 3
Polysomnography Referral for Any Reason 33 4
Mental Health Clinic Referral 13 4
Posttraumatic Stress Disorder Clinic Referral 1 1
Substance Abuse Outpatient Clinic Referral 4 1
2.Primary Outcome
Title Diary Sleep: Total Wake Time and Total Sleep Time
Hide Description Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.
Time Frame 10 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description:

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Overall Number of Participants Analyzed 68 69
Mean (Standard Deviation)
Unit of Measure: minutes
Total Sleep Time 401.2  (69.9) 397.0  (75.9)
Total Wake Time 59.7  (42.0) 79.6  (58.7)
3.Primary Outcome
Title Sleep Efficiency
Hide Description Changes in sleep from baseline to subsequent follow-up periods were evaluated using both actigraphy and electronic diaries via a personal digital assistant (PDA). Primary outcome measures derived from the PDA included total sleep time (TST), total wake time (TWT: SOL+WASO), and sleep efficiency (SE). Wrist Actigraphy. Mini-Mitter® Actiwatch actigraphs were used to derive the primary objective estimates of TST, TWT, and SE. Mean values of TST, TWT and SE were obtained for each participant at baseline, 5 months and 10 months post-randomization and served as the actigraphic dependent measures in study analyses.
Time Frame 10 Months after Baseline
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all participants was included.
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description:

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Overall Number of Participants Analyzed 68 69
Mean (Standard Deviation)
Unit of Measure: percentage of time in bed spent sleeping
87  (9.7) 83.5  (11.7)
4.Primary Outcome
Title Sleep Quality
Hide Description Changes in overall sleep quality were evaluated using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rating scale that yields a quantitative index of general sleep quality/disturbances. The PSQI is composed of 4 open-ended questions and 19 self-rated items (0-3 scale) assessing sleep quality and disturbances over a 1-month interval. The PSQI yields a global score of sleep quality ranging from 0 to 21. A score of <= 5 on the PSQI is considered normal sleep quality.
Time Frame 10 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all participants were included in analyses.
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description:

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Overall Number of Participants Analyzed 68 69
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.3  (3.7) 9.5  (3.5)
5.Secondary Outcome
Title Sleepiness
Hide Description Changes in subjectively assessed daytime sleep propensity were measured using the Epworth Sleepiness Scale (ESS), a commonly employed in both sleep research and clinical applications. The ESS items inquire about the chance of dozing off in each 8 different situations. Responses are rated on a 4 point scale reflecting the respondents perceived likelihood of falling asleep. To quanitfy this outcome, the percentage of participants achieving normal sleep (less than 10 on ESS) was compared across arms at 10 months.
Time Frame 10 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description:

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
Overall Number of Participants Analyzed 68 69
Measure Type: Number
Unit of Measure: percentage of participants
69 50
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sleep Specialty Consultation Treatment as Usual
Hide Arm/Group Description

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.

Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
All-Cause Mortality
Sleep Specialty Consultation Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sleep Specialty Consultation Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/69 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sleep Specialty Consultation Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   0/68 (0.00%)   0/69 (0.00%) 
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
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.
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
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 )
First Submitted: October 18, 2006
First Posted: October 20, 2006
Results First Submitted: September 9, 2014
Results First Posted: November 5, 2014
Last Update Posted: April 24, 2015