Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 11:35 PM
Study NCT ID:
NCT07302893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Digital Sleep Program to Improve Sleep Among New Parents
Sponsor:
Udisense DBA Nanit
Organization:
Study Overview
Official Title:
Evaluation of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population Among New Parents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sleep disturbances are highly prevalent during the postpartum period, with an estimated 40-60% of new parents experiencing inadequate sleep. Although a certain degree of acute sleep disruption is expected after childbirth, excessive or prolonged disturbances can pose significant risks, including poorer cardiometabolic and mental health, impaired cognitive performance, and challenges in bonding with the infant. In addition, untreated insomnia in the perinatal period can lead to more chronic forms of insomnia in some individuals that extends beyond the perinatal period.
Cognitive Behavioral Therapy for Insomnia (CBT-I) is widely recognized as the gold standard treatment for chronic insomnia, demonstrating robust efficacy in diverse populations. However, its applicability in the postpartum period remains underexplored. New parents face a distinct set of sleep challenges, most notably, a significant loss of control over their sleep schedules due to infant care demands. This unpredictability complicates the implementation of core CBT-I techniques such as sleep restriction and stimulus control. Additionally, postpartum parents often experience heightened fatigue, limited time, and cognitive overload, potentially reducing their ability to engage with and retain behavioral or educational interventions.
This study addresses a significant gap in sleep health research by evaluating whether a modified digital CBT-I intervention, enhanced with brief meditation content, can improve self-reported sleep outcomes in new parents. By including both immediate (post-intervention) and longer-term (3-month follow-up) outcomes, the study aligns with broader public health goals of reducing mental health morbidity and improving functioning in the perinatal population.
The Headspace Health Sleep Program is an 18 day program based on CBT-I, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Cognitive Behavioral Therapy for Insomnia (CBT-I) is widely recognized as the gold standard treatment for chronic insomnia, demonstrating robust efficacy in diverse populations. However, its applicability in the postpartum period remains underexplored. New parents face a distinct set of sleep challenges, most notably, a significant loss of control over their sleep schedules due to infant care demands. This unpredictability complicates the implementation of core CBT-I techniques such as sleep restriction and stimulus control. Additionally, postpartum parents often experience heightened fatigue, limited time, and cognitive overload, potentially reducing their ability to engage with and retain behavioral or educational interventions.
This study addresses a significant gap in sleep health research by evaluating whether a modified digital CBT-I intervention, enhanced with brief meditation content, can improve self-reported sleep outcomes in new parents. By including both immediate (post-intervention) and longer-term (3-month follow-up) outcomes, the study aligns with broader public health goals of reducing mental health morbidity and improving functioning in the perinatal population.
The Headspace Health Sleep Program is an 18 day program based on CBT-I, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Detailed Description:
The purpose of the study is to examine the effectiveness of the Headspace Health Sleep Program for improving subjective sleep quality (i.e., self-reported surveys) in a population of new parents with sleep disturbances. The study will employ a 2-arm app-based intervention involving 1 active intervention (i.e., Headspace Health Sleep Program) and a waitlist control for a duration of 3 months.
A set of outcome measures will be used to evaluate the Headspace Health Sleep Program vs. a waitlist control group. The Insomnia Severity Index (ISI) will be used as a primary outcome measure as well as the Sleep Diary. In addition, secondary outcome measures include Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10) and General Anxiety Disorder-7 (GAD-7). Baseline measures will be taken prior to randomization, and at post-intervention. 3 months following the post-intervention assessment, participants will again be asked to report sleep quality using self-reported surveys.
Eligible participants will complete a one-week baseline assessment period during which they will be provided with a sleep diary. Each morning, they will receive a brief EMA prompt to record sleep-related information from the previous night. Following the 1-week baseline assessment period, participants will be asked to complete baseline questionnaires (i.e., ISI, PSQI, PSS-10, GAD7). They will then be randomized into one of two groups (Headspace Health Sleep Program or waitlist control). Having completed the intervention, participants will be scheduled for the 1-week post-intervention assessment period. Participants will again complete the sleep diary. At the end of this 1-week post-intervention assessment period, participants will complete questionnaires (i.e., ISI, PSQI, PSS-10, GAD7). 3 months following the post-intervention, participants will be asked to complete the sleep diary for a 1-week follow-up assessment period and in addition the ISI, PSQI, PSS-10, and GAD7.
A set of outcome measures will be used to evaluate the Headspace Health Sleep Program vs. a waitlist control group. The Insomnia Severity Index (ISI) will be used as a primary outcome measure as well as the Sleep Diary. In addition, secondary outcome measures include Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10) and General Anxiety Disorder-7 (GAD-7). Baseline measures will be taken prior to randomization, and at post-intervention. 3 months following the post-intervention assessment, participants will again be asked to report sleep quality using self-reported surveys.
Eligible participants will complete a one-week baseline assessment period during which they will be provided with a sleep diary. Each morning, they will receive a brief EMA prompt to record sleep-related information from the previous night. Following the 1-week baseline assessment period, participants will be asked to complete baseline questionnaires (i.e., ISI, PSQI, PSS-10, GAD7). They will then be randomized into one of two groups (Headspace Health Sleep Program or waitlist control). Having completed the intervention, participants will be scheduled for the 1-week post-intervention assessment period. Participants will again complete the sleep diary. At the end of this 1-week post-intervention assessment period, participants will complete questionnaires (i.e., ISI, PSQI, PSS-10, GAD7). 3 months following the post-intervention, participants will be asked to complete the sleep diary for a 1-week follow-up assessment period and in addition the ISI, PSQI, PSS-10, and GAD7.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: