Direct Referral for Apnea Monitoring

Obstructive Sleep Apnea (OSA) Clinical Trial

— DREAM  

Official title:

Improving Access to Sleep Apnea Care: A Pragmatic Study of New Consultation Models

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05419323
• Other study ID #: IIR 15-339
• Secondary ID: 19-27
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2024
• Source: VA Office of Research and Development
• Contact: Kathleen F Sarmiento, MD MPH
• Phone: (410) 818-9643
• Email: Kathleen.Sarmiento[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary objective of this project is to compare a health care delivery model, Direct Referral for Apnea Monitoring (DREAM), with initial in-person (Traditional) clinic appointments for Veterans at risk for obstructive sleep apnea (OSA). A secondary objective is to determine the negative predictive value (NPV) of home sleep apnea testing (HSAT).

Description:

Patients referred to one of 3 participating VA sleep medicine clinics (San Francisco VA, VA Portland or VA Pittsburgh) for OSA will be assigned either to the Traditional clinical pathway (which might include an initial encounter with a sleep care provider through in-person visits, telephone clinics, or video conferencing) or the DREAM pathway which will omit the initial encounter with a care provider. After a clinician conducts a chart review of medical records, patients in the DREAM pathway will be referred for sleep testing. All patients will be tracked from the time of referral until 90-days past the initiation of treatment. To determine the NPV of HSAT, results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Concurrent PSG and HSAT studies will be done at Portland, Pittsburgh, and San Francisco.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2413
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Age 18 years Agrees to be seen by a VA sleep program Reason for referral to sleep clinic:

New OSA Evaluation Exclusion Criteria: Age < 18 years Declines to be seen by a VA sleep program Reason for referral to sleep clinic: anything other than a new OSA evaluation

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania
United States	VA Portland Health Care System, Portland, OR	Portland	Oregon
United States	San Francisco VA Medical Center, San Francisco, CA	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	San Francisco Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (13)

Atwood CW, Boudreau EA, Folmer RL, Kuna ST, Pineda L, Reichert J, Sarmiento K, Thompson W, Whooley M, Zhang N, Yarbrough WC. 1170 Trends in Sleep Apnea Testing Among Veterans Participating in a Rural Health-Focused Telesleep Medicine Program. [Abstract]. Sleep Medicine Reviews. 2020 Apr 1; 43(Supplement 1):A447.

Atwood W, Smith C, Totten A, Boudreau EA, Sarmiento K, Hahn Z, Folmer RL, Tock J, Hotchkiss J. Good Sleep Care: Geospatial Optimization of Distant Sleep Care in the VA. [Abstract]. Sleep. 2022 Jun 1; 45(Suppl 1):A164.

Chang YHA, Folmer RL, Shasha B, Shea JA, Sarmiento K, Stepnowsky CJ, Lim D, Pack A, Kuna ST. Barriers and facilitators to the implementation of a novel web-based sleep apnea management platform. Sleep. 2021 Apr 9;44(4):zsaa243. doi: 10.1093/sleep/zsaa243. — View Citation

Chun VS, Whooley MA, Williams K, Zhang N, Zeidler MR, Atwood CW, Folmer RL, Totten AM, Smith CJ, Boudreau EA, Reichert JM, Sarmiento KF. Veterans Health Administration TeleSleep Enterprise-Wide Initiative 2017-2020: bringing sleep care to our nation's vet — View Citation

Folmer RL, Boudreau EA, Atwood CW, Smith CJ, Totten AM, Tock JL, Chilakamarri P, Sarmiento KF. Study protocol to assess de-implementation of the initial provider encounter for diagnosis and treatment of obstructive sleep apnea: the DREAM (Direct Referral for Apnea Monitoring) Project. BMC Pulm Med. 2022 Apr 2;22(1):123. doi: 10.1186/s12890-022-01899-y. — View Citation

Folmer RL, Smith CJ, Boudreau EA, Hickok AW, Totten AM, Kaul B, Stepnowsky CJ, Whooley MA, Sarmiento KF. Prevalence and management of sleep disorders in the Veterans Health Administration. Sleep Med Rev. 2020 Dec;54:101358. doi: 10.1016/j.smrv.2020.101358. Epub 2020 Jul 20. — View Citation

Folmer RL, Smith CJ, Boudreau EA, Totten AM, Chilakamarri P, Atwood CW, Sarmiento KF. Sleep disorders among rural Veterans: Relative prevalence, comorbidities, and comparisons with urban Veterans. J Rural Health. 2023 Jun;39(3):582-594. doi: 10.1111/jrh.1 — View Citation

Folmer RL. Unresolved Issues Associated with Transcranial Magnetic Stimulation (TMS) Treatment of Chronic Tinnitus. J Clin Med. 2023 Jul 12;12(14):4648. doi: 10.3390/jcm12144648. — View Citation

Hahn Z, Hotchkiss J, Atwood C, Smith C, Totten A, Boudreau E, Folmer R, Chilakamarri P, Whooley M, Sarmiento K. Travel Burden as a Measure of Healthcare Access and the Impact of Telehealth within the Veterans Health Administration. J Gen Intern Med. 2023 — View Citation

Mazzotti DR, Haendel MA, McMurry JA, Smith CJ, Buysse DJ, Roenneberg T, Penzel T, Purcell S, Redline S, Zhang Y, Merikangas KR, Menetski JP, Mullington J, Boudreau E. Sleep and circadian informatics data harmonization: a workshop report from the Sleep Res — View Citation

Salinsky M, Evrard C, Joos S, Boudreau E. Utility of mental health and sleep screening questionnaires for patients admitted to a seizure monitoring unit. Epilepsy Behav. 2021 Oct;123:108237. doi: 10.1016/j.yebeh.2021.108237. Epub 2021 Aug 7. — View Citation

Sarmiento K, Kuna S, Boudreau EA, Atwood C, Pineda L, Thompson W, Zeidler M, Fields B, Uzzaman A, Totten A, Smith C, Folmer RL, Williams K, Zhang N, Whooley M. VHA's TeleSleep Program improves rural Veteran access to sleep care through expansion of telehealth networks. [Abstract]. Sleep. 2021 May 3; 44(Suppl 2):A317-A318.

Sarmiento KF, Boudreau EA, Smith CJ, Kaul B, Johnson N, Folmer RL. Effects of Computer-Based Documentation Procedures on Health Care Workload Assessment and Resource Allocation: An Example From VA Sleep Medicine Programs. Fed Pract. 2020 Aug;37(8):368-374. doi: 10.12788/fp.0023. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from referral	For Arms 1 & 2: Compare time from referral to sleep testing and treatment of OSA	1 year
Primary	PAP adherence	For Arms 1 & 2: PAP treatment adherence (for example, Percentage of days with usage >= 4 hours) between Traditional and DREAM clinical pathways	1 year
Primary	AHI scores	For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures	4 years