Direct Referral for Apnea Monitoring

NCT05419323 | Completed

• 2 other identifiers: IIR 15-33919-27
• Study Type: observational
• Target: 6,501
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Obstructive Sleep Apnea (OSA)

Keywords

sleep apnea syndromes; polysomnography; home sleep apnea testing

Outcome Measures

Primary Outcomes (3)

• Time from referral

  For Arms 1 \& 2: Compare time from referral to sleep testing and treatment of OSA

  1 year

• 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

• AHI scores

  For Arm 3: Compare apnea-hypopnea index (AHI) scores between HSAT and PSG procedures

  4 years

Study Arms (3)

Traditional clinical pathway for OSA

After referral, patients will have an initial encounter with a sleep care provider which might include in-person visits, telephone clinics, or video conferencing. Intervention/Treatment: Patients in Arm 1 will receive routine care for OSA at one of the participating VA Sleep Medicine clinics.

DREAM clinical pathway for OSA

After referral, patients will not have an 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. Intervention/Treatment: Patients in Arm 2 will receive routine care for OSA at one of the participating VA Sleep Medicine clinics.

Negative predictive value of HSAT

Results of sleep tests will be compared for patients who undergo both HSAT and polysomnographic (PSG) procedures. Intervention/Treatment: Patients in Arm 3 will undergo a) HSAT sleep testing followed by PSG testing, or b) simultaneous administration of PSG and HSAT sleep testing.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will include patients referred for new OSA evaluations at Sleep Medicine clinics at the 3 VA study sites. Participants will be identified via a review of their medical records by the PIs (study physicians) after they are referred for OSA evaluations at the 3 study sites.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (3)

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563, United States

Location

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (16)

• 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.

  PMID: 32791487 BACKGROUND

• 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.

  PMID: 32908344 BACKGROUND

• 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.

  PMID: 33216916 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 34375800 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35366836 BACKGROUND

• 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.

  BACKGROUND

• 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.12722. Epub 2022 Nov 5.

  PMID: 36333991 RESULT

• 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 veterans. J Clin Sleep Med. 2023 May 1;19(5):913-923. doi: 10.5664/jcsm.10488.

  PMID: 36708262 RESULT

• 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 Jul;38(Suppl 3):805-813. doi: 10.1007/s11606-023-08125-3. Epub 2023 Jun 20.

  PMID: 37340257 RESULT

• 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.

  PMID: 37510763 RESULT

• 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 Research Society and Sleep Research Network. Sleep. 2022 Jun 13;45(6):zsac002. doi: 10.1093/sleep/zsac002.

  PMID: 35030631 RESULT

• Belkora JK, Ortiz DeBoque L, Folmer RL, Totten AM, Williams K, Whooley MA, Boudreau E, Atwood CW, Zeidler M, Rezayat T, Chilakamarri P, Sarmiento KF. Sustainment of the TeleSleep program for rural veterans. Front Health Serv. 2023 Nov 10;3:1214071. doi: 10.3389/frhs.2023.1214071. eCollection 2023.

  PMID: 38028943 RESULT

• Atwood C, Boudreau EA, Sarmiento K, Williams K, Totten A, Folmer RL, Wholey M. 1058 Experience of VA Telesleep Medicine Following the COVID Pandemic. [Abstract]. Sleep. 2024 May 1; 47(Suppl 1):A454-A455.

  RESULT

• Shamim-Uzzaman QA, Zeidler MR, Boudreau EA, Chowdhuri S, Donovan LM, El-Solh A, Freire AX, Gottlieb DJ, Jindal RD, Hesselbacher S, Koo B, Kuna S, Lim MM, Mina S, Stepnowsky C, Tamanna S, Tobias L, Ulmer C, Yaggi K, Surani S, Atwood C, Sarmiento K, Ioachimescu OC. Sleep research, quality and implementation priorities in the Veterans Health Administration: a white paper. J Clin Sleep Med. 2025 Oct 1;21(10):1787-1797. doi: 10.5664/jcsm.11734.

  PMID: 40375810 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kathleen Fumiko Sarmiento, MD MPH

  San Francisco VA Medical Center, San Francisco, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: August 1, 2020
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: From study initiation to completion, 2020-2025

Locations

US (3)