An interventional study of Sleep Specialty Consultation in Sleep Disorders, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-24.
Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment
Sleep disorders are prevalent health problems that reduce quality of life, increase risks for medical disease, and enhance healthcare costs/utilization. Only a small proportion of these cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were prescribed pharmacologic treatment for insomnia by their primary care providers.
Sleep disorders are prevalent health problems that reduce quality of life, increase risks for medical disease, and enhance healthcare costs/utilization. Only a small proportion of these cases are diagnosed in primary care. Pilot data from this VA suggest that sleep disorders are not adequately managed in a primary care setting: 33% of veterans with an insomnia complaint had an undiagnosed primary sleep disorder (e.g., sleep apnea), and 50% of these patients were prescribed pharmacologic treatment for insomnia by their primary care providers. This project tests the incremental benefits of adding a one-time sleep specialty consultation (SSC) to usual primary care for reducing sleep disturbance, diurnal dysfunction, quality of life concerns and health care utilization among veterans enrolled in the DVAMC Primary Care Clinics. The SSC will consist 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. Study hypotheses predict that patients who receive an SSC with feedback to their primary care providers will show greater improvements in sleep, mood, quality of life, and patient satisfaction, as well as larger reductions in health care utilization than will those who receive usual care alone. This is a randomized, wait-list control, clinical intervention study of 300 veterans with sleep complaints. Eligibility criteria include: sleep complaint for > 1 month duration, Pittsburgh Sleep Quality Index score > 5; mental status score > 24 on Folstein MMSE, no unstable medical or psychiatric disorder, and approval of primary provider. The SSC intervention consists of a clinician-administered structured interview assessing sleep pathology, plus manualized feedback to patients and primary care providers. Participants are randomly assigned to SSC or Wait List Control (WLC) conditions. Measures of sleep, mood, quality of life, and patient satisfaction are obtained at enrollment and at 5- and 10-month follow-up. Computerized utilization data is obtained for the 10 months prior to and 10 months following enrollment. A series of multivariate and univariate statistical tests will be conducted.
Study findings should provide important new information about managing both the sleep problems and overall health care utilization patterns of patients with sleep complaints presenting in VA primary care settings. If SSC-evaluated patients show substantial reductions in their VA inpatient/outpatient utilization, this finding could have important cost-saving implications to the VA system.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 156 is above the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Participants randomized to receive a one-time sleep consultation at beginning of study
Behavioral: Sleep Specialty Consultation
Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
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.
Provider Adherence to Sleep Specialist Recommendations
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
Diary Sleep: Total Wake Time and Total Sleep Time
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
Sleep Efficiency
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
Sleep Quality
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
Sleepiness
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
| Milestone | Sleep Specialty Consultation | Treatment as Usual |
|---|---|---|
| Started | 68 | 69 |
| Completed | 60 | 64 |
| Not completed | 8 | 5 |
| Withdrew: Lost to follow-up | 8 | 4 |
| Withdrew: Health condition | 0 | 1 |
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.
| participants | Sleep Specialty Consultation | Treatment as Usual |
|---|---|---|
| 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 |
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.
| minutes | Sleep Specialty Consultation | Treatment as Usual |
|---|---|---|
| Total Sleep Time | 401.2 ± 69.9 | 397.0 ± 75.9 |
| Total Wake Time | 59.7 ± 42.0 | 79.6 ± 58.7 |
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.
| percentage of participants | Sleep Specialty Consultation | Treatment as Usual |
|---|---|---|
| Sleepiness | 69 | 50 |
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.
| percentage of time in bed spent sleeping | Sleep Specialty Consultation | Treatment as Usual |
|---|---|---|
| Sleep Efficiency | 87 ± 9.7 | 83.5 ± 11.7 |
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.
| units on a scale | Sleep Specialty Consultation | Treatment as Usual |
|---|---|---|
| Sleep Quality | 8.3 ± 3.7 | 9.5 ± 3.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sleep Specialty Consultation | — | 0/68 (0%) | 0/68 (0%) |
| Treatment as Usual | — | 0/69 (0%) | 0/69 (0%) |
Intent to Treat: All participants who were randomized to treatment condition.
| Age, Continuous(years) | Sleep Specialty Consultation | Treatment as Usual | Total |
|---|---|---|---|
| Mean | 55.0 ± 13.7 | 55.9 ± 13.4 | 55.4 ± 13.5 |
| Sex: Female, Male(Participants) | Sleep Specialty Consultation | Treatment as Usual | Total |
|---|---|---|---|
| Female | 14 | 15 | 29 |
| Male | 54 | 54 | 108 |
| Region of Enrollment(participants) | Sleep Specialty Consultation | Treatment as Usual | Total |
|---|---|---|---|
| United States | 68 | 69 | 137 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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US Department of Veterans Affairs