Evaluation of Digital Sleep Program to Improve Sleep Among New Parents

Conditions

• Insomnia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Digital CBT-I — BEHAVIORAL
  Headspace 18-session sleep program

Study Details

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).

Key Dates

Start date

Jan 15, 2026

Status verified

Dec 2025

Primary completion

Jul 15, 2026

Completion

Sep 15, 2026

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Arms

• Experimental: Digital CBT-I recipients
  instructed to follow the 18-session Headspace sleep program daily
• No Intervention: No intervention
  asked to maintain their regular routines

Primary Outcome Measure

Insomnia Severity Index (ISI) score [ Time Frame: Change from baseline to immediately post-intervention and 3 months follow-up ]

Central Contacts

• Maristella Lucchini, Senior Clinical Researcher at Nanit, PhD
  1-866-696-2648
  [email protected]
• Natalie Barnett, VP of Clinical Research at Nanit, PhD
  [email protected]

Locations (1)

Find similar trials in New York, NY

Related Studies

• Digital CBT for Insomnia and Depression
  Recruiting · University of Rochester · Rochester, New York
• Deaf CBT-TS to Reduce Suicide Risk
  Not Yet Recruiting · University of Rochester · Rochester, New York
• Deep Sleep in Older Adults
  PHASE2 · Not Yet Recruiting · Proactive Life Inc · New York, New York
• NeuroFinance Human Stress Trial During Financial and Informational Volatility
  Not Yet Recruiting · Truway Health, Inc. · New York, New York