NCT05694780

Brief Summary

Sleep disturbances are one of the most frequent complaints brought to the healthcare professionals during routine prenatal care visits.The purpose of this study is to develop and evaluate a Sleep Training and Education Program (STEP) for improving sleep and health in women during pregnancy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 23, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

January 5, 2023

Last Update Submit

May 18, 2025

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Sleep by actigraphy

    Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist

    Through study completion, an average of 16 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

Women in the intervention group will receive standard obstetric care plus the STEP intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Behavioral: Sleep intervention

Control

NO INTERVENTION

Women in the control group will receive standard obstetric care.

Interventions

Sleep interventionBEHAVIORAL

Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.

Experimental

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • During the first trimester of pregnancy
  • Singleton pregnancies

You may not qualify if:

  • Women have pregnancy-related complications
  • Women have diagnosed a psychiatric or sleep disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei, 10051, Taiwan

RECRUITING

Study Officials

  • Shao-Yu Tsai

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shao-Yu Tsai

CONTACT

0905676805stsai@ntu.edu.tw

Jia-Chun Huang

CONTACT

(02)3366-7178ntuhrec@ntuh.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 23, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

May 21, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)