Direct Referral for Apnea Monitoring

NCT ID: NCT05419323

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

6501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2026-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea (OSA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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San Francisco Veterans Affairs Medical Center

FED

Sponsor Role collaborator

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kathleen Fumiko Sarmiento, MD MPH

Role: PRINCIPAL_INVESTIGATOR

San Francisco VA Medical Center, San Francisco, CA

Locations

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San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

Site Status

VA Portland Health Care System, Portland, OR

Portland, Oregon, United States

Site Status

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 32791487 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32908344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33216916 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 34375800 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 35366836 (View on PubMed)

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.

Reference Type 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.

Reference Type RESULT
PMID: 36333991 (View on PubMed)

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.

Reference Type RESULT
PMID: 36708262 (View on PubMed)

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.

Reference Type RESULT
PMID: 37340257 (View on PubMed)

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.

Reference Type RESULT
PMID: 37510763 (View on PubMed)

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.

Reference Type RESULT
PMID: 35030631 (View on PubMed)

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.

Reference Type RESULT
PMID: 38028943 (View on PubMed)

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.

Reference Type 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.

Reference Type RESULT
PMID: 40375810 (View on PubMed)

Other Identifiers

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19-27

Identifier Type: OTHER

Identifier Source: secondary_id

IIR 15-339

Identifier Type: -

Identifier Source: org_study_id

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