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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05530863
Other study ID # 848419
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date September 27, 2026

Study information

Verified date October 2023
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women


Description:

This is a randomized, 60-day research study that is evaluating the effect of a simplified behavioral relaxation intervention in pregnant and postpartum patients aimed to improve their insomnia symptoms. The investigators will be enrolling a total of 20 patients who indicate self-reported insomnia symptoms.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 20
Est. completion date September 27, 2026
Est. primary completion date September 27, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Age between 18 and 55 - In second or third trimester of pregnancy (Gestation weeks 18-32) - Able to speak, read and write fluent English - Has regular access to a smartphone and/or smart tablet - sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for =3 nights/week, must persist for at least 1 month Exclusion Criteria: - Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period. - Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Assisted Therapy
The participant will receive coaching calls and support
Sleep Hygiene
Standard Sleep Hygiene instructions.

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary PSQI, Sleep Quality Measured by a single item score, sleep quality is the measurement of how restful and restorative the sleep of an individual is. Pittsburgh Sleep Quality Index: Well- known questionnaire used to measure sleep quality in various patient groups. For overall sleep quality, the minimum score= 0 (better) and the maximum score=3 (worse). 30 days
Primary Total Wake Time, Sleep Diary A sleep diary will be used to gather information about the participants daily sleep pattern and schedule; gold standard of care for insomnia. This instrument will also be used to check adherence to the Gratification practice of the ART intervention. This will be administered during pre-screening and intervention. 30 days
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