Evaluation of Digital Sleep Program to Improve Sleep Among New Parents

Udisense DBA Nanit

Status

Not yet enrolling

Conditions

Insomnia

Treatments

Behavioral: Digital CBT-I

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07302893

Nanit 2025-18

Details and patient eligibility

About

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).

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

First time parents with infants between 4-12 months of age
Caregiver is over 18 years old
Caregiver meets clinical threshold for insomnia (11 or greater on the ISI)
Own a smartphone that can support downloaded apps
Fluency in English

Exclusion criteria

A diagnosis of any of the following conditions: self-reported schizophrenia, psychosis, depression, self-harm bipolar disorder, seizure disorder, substance use disorder, recent trauma to the head or brain damage, severe cognitive impairment, serious physical health concerns necessitating surgery or with a prognosis of less than 6 months, or pregnancy. Two or more hospitalizations within the past 6 months for psychiatric reasons.
Prior enrollment in another CBT-I program
Regular mindfulness meditation practice
Diagnosed sleep disordered breathing
Parents of infants with health complications