Sleep Initiation and Maintenance DisordersNCT05530863
Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
A study testing Assisted Therapy and Sleep Hygiene in people with Sleep Initiation and Maintenance Disorders and Pregnancy Related, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders, Pregnancy Related
- What is being tested?
- Assisted Therapy and Sleep Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to 27 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women
Read the 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.
- Being tested
- Assisted Therapy, Sleep Hygiene
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assisted TherapyBehavioural
The participant will receive coaching calls and support
Sleep HygieneBehavioural
Standard Sleep Hygiene instructions.
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene | Active comparator | 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 Receives: Behavioral: Sleep Hygiene |
| ART and Sleep Hygiene | Experimental | 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 Receives: Behavioral: Assisted Therapy; Behavioral: Sleep Hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start1 Apr 2022
- Primary completion27 Sep 2026 (estimated)
- Study completion27 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalaka Gooneratne, University of Pennsylvania
- Investigators
- Nalaka Gooneratne, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530863
- Sponsor's protocol ID
- 848419
- Status last verified
- Dec 2025
- First submitted
- 24 Mar 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Relaxation Approaches for Insomnia in Pregnant Patients
- ClinicalTrials.gov ID
- NCT05530863
- Acronym / sponsor ID
- 848419
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 27 Sep 2027 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene | Active comparator | Behavioral: Sleep HygieneThis arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding |
| ART and Sleep Hygiene | Experimental | Behavioral: Assisted Therapy, Behavioral: Sleep HygieneThis arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assisted TherapyThe participant will receive coaching calls and support | Behavioural | ART and Sleep Hygiene |
| Sleep HygieneStandard Sleep Hygiene instructions. | Behavioural | ART and Sleep Hygiene, Sleep Hygiene |
Primary outcome
PSQI, Sleep Quality
Time frame: 30 days
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
Time frame: 30 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nalaka Gooneratne, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assisted Therapy and Sleep Hygiene in people with Sleep Initiation and Maintenance Disorders and Pregnancy Related, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI, Sleep Quality (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.