Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05694780

Collaborator

(none)

300

Enrollment

Location

Arms

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related	Behavioral: Sleep intervention	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Sleep Health Care in Pregnancy: A Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 Standard obstetric care plus the sleep intervention which is a 8-week program based on sleep hygiene education and cognitive-behavioral training.
No Intervention: Control Women in the control group will receive standard obstetric care.

Arm

Intervention/Treatment

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

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

No Intervention: Control

Women in the control group will receive standard obstetric care.

Outcome Measures

Primary Outcome Measures

Sleep by actigraphy [Through study completion, an average of 16 weeks]
Actigraphy is an objective sleep measurement method that assesses physical motion through a small device worn on the non-dominant wrist

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

During the first trimester of pregnancy
Singleton pregnancies

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	10051

Sponsors and Collaborators

National Taiwan University Hospital

Investigators

Principal Investigator: Shao-Yu Tsai, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT05694780

Other Study ID Numbers:

202209036RINC

First Posted:

Jan 23, 2023

Last Update Posted:

Jan 23, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jan 23, 2023