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App-based sleep program for new parents with insomnia

Tests a digital sleep program for insomnia in new parents.

Key facts

Who runs it
Udisense DBA Nanit
Where
New York, United StatesSee the site
Trial code
Registry title
Evaluation of Digital Sleep Program to Improve Sleep Among New Parents
Status
Not yet recruiting
People taking part
250 people, planned
Started
15 Jan 2026
Planned end
15 Sept 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Digital CBT-I
Record updated
24 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for first-time parents of babies aged 4-12 months who have insomnia. It tests an app-based sleep program.

Age
Over 18 years old (minimum age 18 Years).
Sex
All sexes can join.
Disease stage
Insomnia at a clinical level: a score of 11 or greater on the ISI (Insomnia Severity Index).
Earlier treatment
People who were in another CBT-I program before cannot join. People who regularly practise mindfulness meditation cannot join.

Main reasons for not taking part

  • Schizophrenia, psychosis, depression, self-harm, bipolar disorder, seizures, substance use disorder, head injury or severe memory and thinking problems
  • Two or more hospital stays for mental health reasons in the past 6 months
  • Serious physical illness needing surgery, or expected to live less than 6 months, or being pregnant
  • Diagnosed breathing problems during sleep
  • Baby has health complications

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Prior enrollment in another CBT-I program
  • 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
  • Regular mindfulness meditation practice
  • Diagnosed sleep disordered breathing
  • Parents of infants with health complications

Where in United States

  • Nanit officeNew York, United StatesContact: Natalie Barnett, VP of Clinical Research at Nanit, PhDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 2 groups in the trial

  • Digital CBT-I recipientsTreatment being tested

    instructed to follow the 18-session Headspace sleep program daily

    Treatment: Digital CBT-I

  • No interventionNo study treatment, for comparison

    asked to maintain their regular routines

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population Among New Parents
Plain-language title
App-based sleep program for new parents with insomniaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
24 December 2025