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Obstructive Sleep Apnea (OSA)DREAMNCT05419323

Direct Referral for Apnea Monitoring

An observational study of Obstructive Sleep Apnea (OSA), run by VA Office of Research and Development at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obstructive Sleep Apnea (OSA)
How many people
6,501 participants
Where
3 sitesUnited States
Study dates
1 Aug 2020to 31 Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240

  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121-1563

Other trials in United States

About this study

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

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).

Read the detailed 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.

Keywords
sleep apnea syndromes, polysomnography, home sleep apnea testing
Medical subject headings
Sleep Apnea, Obstructive, Sleep Apnea Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05419323
Study groupRoleWhat they receive
Traditional clinical pathway for OSAAfter 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 OSAAfter 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 HSATResults 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time from referral

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

    Measured: 1 year

  2. PAP adherence

    For Arms 1 \& 2: PAP treatment adherence (for example, Percentage of days with usage >= 4 hours) between Traditional and DREAM clinical pathways

    Measured: 1 year

  3. AHI scores

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

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2022
  2. Study start1 Aug 2020
  3. Primary completion31 Mar 2026
  4. Study completion31 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
6,501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05419323
Sponsor's protocol ID
IIR 15-339
Other IDs
19-27
Acronym
DREAM
Status last verified
May 2026
First submitted
10 Jun 2022
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared at the conclusion of this study.

Publications

  • 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.

    PubMed 32791487

  • 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.

    PubMed 32908344

  • 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.

    PubMed 33216916

  • 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.

  • 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.

    PubMed 34375800

  • 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.

  • 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.

    PubMed 35366836

  • 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.

  • 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.

    PubMed 36333991

  • 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.

    PubMed 36708262

  • 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.

    PubMed 37340257

  • 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.

    PubMed 37510763

  • 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.

    PubMed 35030631

  • 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.

    PubMed 38028943

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea (OSA), run by VA Office of Research and Development at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from referral (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05419323, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.

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