Protocol Section

Protocol Section

The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.

Protocol Section path is as follows:

Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)

Protocol Section


Ignite Creation Date: 2025-12-24 @ 11:14 PM
Ignite Modification Date: 2025-12-24 @ 11:14 PM
NCT ID: NCT06281756
Description: The investigators have extensive experience preparing data and documentation to be available for public. They agree to abide by the principles for sharing research resources described by the National Heart, Lung, Blood Institute (NHLBI). A copy of the data will be uploaded to the NHLBI Biologic Specimen and Data Repositories Information Coordinating Center (BioLINCC) repository. The datasets will not include any personal identifiers related to participants or clinical sites. Dates will be de-identified through a date-shifting algorithm to mask actual dates while maintaining a relation to the epoch in which events occurred. Data tables will be exported in comma-separated format, readable by statistical software. Variable dictionaries and code books, detailing variable description, format, value domain and labels, will be produced. Raw data files for polysomnogram/actigraphy/cortisol will also be made available, ensuring that data are linkable to study data and data are de-identified.
Study: NCT06281756
Study Brief: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia