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. 2022 Sep 24;23:806. doi: 10.1186/s13063-022-06753-4
Row Reporting Item SPIRIT Item Details
1 Trial registration #2a, #2b clinicaltrial.gov, NCT03109210, registered on April 12, 2017
2 Protocol version #3 25 Mar 2020. Version 2, updated to add remote visit procedures in adaptation to COVID-19 pandemic
3 Funding #4 National Heart Lung and Blood Institute, R01HL130559, 9/1/2016-6/30/2022
4 Author details #5a

Elizabeth Devon Eldridge-Smith, PhD

smithed@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Rachel Manber, PhD

rmanber@stanford.edu

Stanford University

401 Quarry Road, Stanford, CA 94305, USA

Jack Edinger, PhD

edingerj@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Bryan Simmons, MS

simmonsb@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Matthew Strand, PhD

strandm@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Sheila Tsai, PhD

tsais@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Roxane Horberg, MPH

horbergr@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Ann Depew, MA, LPC

depewa@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Rachel Johnson, MA

johnsonr@njhealth.org

National Jewish Health

1400 Jackson St, Denver, CO 80206, USA

Aysha Abraibesh, MPA

aysha.abraibesh@stanford.edu

Stanford University

401 Quarry Road, Stanford, CA 94305, USA

Norah Simpson, PhD

nsimpson@stanford.edu

Stanford University

401 Quarry Road, Stanford, CA 94305, USA

Colin A. Espie, PhD, DSc

colin@bighealth.com

Big Health

461 Bush St #200, San Francisco, CA 94108, USA

University of Oxford

Oxford OX1 2JD, United Kingdom

Clete Kushida, MD, PhD

clete@stanford.edu

Stanford University

450 Broadway Street, Redwood City CA

5 Sponsor contact information #5b

Louis Velasco, Grants Management Specialist,

(301) 827-7977, louis.velasco@nih.gov

6 Role of sponsor #5c The sponsor/funding source is not involved in study design, data collection and analysis, interpretation, writing of the report, or decision to submit for publication
7 Role of committees #5d

Principal investigator and research physician:

Oversight of trial, including supervision of study personnel.

Reviewing progress of study and if necessary agreeing changes to the protocol to facilitate the smooth running of the study

Responsible for trial master files

Study therapists:

Delivery of cognitive behavioral therapy in accordance with study protocol

Site coordinating teams (project manager, study coordinators):

Preparation of protocol and revisions

Preparation and submission of regulatory paperwork

Reporting to pertinent IRBs

Organization of study meetings

Creation of study reports

Recruitment

Study coordination and data collection in adherence to study protocol.

Research administration:

Grant finance management

Contract development and maintenance

Data team (Study statistician, study coordinators):

Preparation of routine data audit reports

Data verification

Randomization

Maintenance of trial data collection system and data entry surveillance

8 Auditing #23 Regulatory oversight is completed through a yearly review of progress completed by the Institutional Review Board of record. Additionally, the study has a Data and Safety Monitoring Board comprised of three sleep medicine experts, which also meets once per calendar year to review the progress of the study and consult on issues related to ethical conduct.
9 Authorship policy #31b Topics suggested for presentation or publication will be circulated to the PIs. The PI of an ancillary study should be considered for lead author of material derived from this study. PIs will be consulted to suggest and justify names for authors.