Evaluation of Digital Sleep Program to Improve Sleep Among New Parents

NCT07302893 | Not Yet Recruiting

• 1 other identifier: Nanit 2025-18
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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).

Conditions

Insomnia

Keywords

postpartum; CBT-I

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI) score

  The ISI is a measure of sleep disturbance severity. ISI is a 7-item, self-report measure for the evaluation of insomnia. Items in the ISI concern difficulties falling asleep, problems staying asleep, daytime symptoms connected to the sleeping problem, and worrying about sleeping too little. Each item is rated from 0 to 4, giving the rating scale a maximum summed score of 28 points. According to the guidelines for interpretation, 0-7 should be interpreted as no clinically significant insomnia, 8-14 as subthreshold insomnia, 15-21 as clinical insomnia of moderate severity, and 22-28 as severe clinical insomnia.

  Change from baseline to immediately post-intervention and 3 months follow-up

• Sleep Diary

  Participants will be asked to complete a daily sleep diary for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment and the 1-week follow-up period. The sleep diary will be used to measure sleep efficiency (SE) and total wake time (TWT). Sleep efficiency will be calculated by dividing the amount of time sleeping in bed by the amount of time spent in bed. Total sleep time will be calculated as the total amount of nightly sleep. In addition, the sleep diary will measure sleep onset latency (SOL), wake after sleep onset (WASO). The sleep diary data will be averaged across one week with a minimum of 4 nights required for inclusion.

  Change from baseline to immediately post-intervention and 3 month follow-up

Secondary Outcomes (3)

• The Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline to immediately post-intervention and 3 months follow-up

• Perceived Stress Scale (PSS-10)

  Change from baseline to immediately post-intervention and 3 months follow-up

• General Anxiety Disorder-7 (GAD-7)

  Change from baseline to immediately post-intervention and 3-months follow-up

Study Arms (2)

Digital CBT-I recipients

EXPERIMENTAL

instructed to follow the 18-session Headspace sleep program daily

Behavioral: Digital CBT-I

No intervention

NO INTERVENTION

asked to maintain their regular routines

Interventions

Digital CBT-I BEHAVIORAL

Headspace 18-session sleep program

Digital CBT-I recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Headspace: collaborator
• Udisense DBA Nanit: lead

Study Sites (1)

Nanit office

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Maristella Lucchini, Senior Clinical Researcher at Nanit, PhD

CONTACT

1-866-696-2648; maristella.lucchini@nanit.com

Natalie Barnett, VP of Clinical Research at Nanit, PhD

CONTACT

natalie.barnett@nanit.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon request after dissemination of results.

Locations

US (1)