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Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Primary Purpose

Sleep Initiation and Maintenance Disorders, Pregnancy Related

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assisted Therapy
Sleep Hygiene
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Initiation and Maintenance Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Sleep Hygiene

ART and Sleep Hygiene

Arm Description

This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding

This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
March 24, 2022
Last Updated
October 16, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT05530863
Brief Title
Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
Official Title
Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
September 27, 2025 (Anticipated)
Study Completion Date
September 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Initiation and Maintenance Disorders, Pregnancy Related

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Hygiene
Arm Type
Active Comparator
Arm Description
This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding
Arm Title
ART and Sleep Hygiene
Arm Type
Experimental
Arm Description
This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding
Intervention Type
Behavioral
Intervention Name(s)
Assisted Therapy
Intervention Description
The participant will receive coaching calls and support
Intervention Type
Behavioral
Intervention Name(s)
Sleep Hygiene
Intervention Description
Standard Sleep Hygiene instructions.
Primary Outcome Measure Information:
Title
PSQI, Sleep Quality
Description
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).
Time Frame
30 days
Title
Total Wake Time, Sleep Diary
Description
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.
Time Frame
30 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalaka Gooneratne, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

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