InsomniaNCT07302893
Evaluation of Digital Sleep Program to Improve Sleep Among New Parents
A study testing Digital CBT-I in people with Insomnia, run by Udisense DBA Nanit at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Digital CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maristella Lucchini, Senior Clinical Researcher at Nanit, PhD contact
Natalie Barnett, VP of Clinical Research at Nanit, PhD contact
United States1 site
Nanit office
New York, New York, 10013
Natalie Barnett, VP of Clinical Research at Nanit, PhD, 1-866-696-2648, natalie.barnett@nanit.com
About this study
Official title: Evaluation of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population Among New Parents
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.
Read more
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).
Read the 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.
- Conditions
- Insomnia
- Being tested
- Digital CBT-I
- Keywords
- postpartum, CBT-I
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital CBT-IBehavioural
Headspace 18-session sleep program
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT-I recipients | Experimental | instructed to follow the 18-session Headspace sleep program daily Receives: Behavioral: Digital CBT-I |
| No intervention | No intervention | asked to maintain their regular routines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change from baseline to immediately post-intervention and 3 month follow-up
Secondary outcomes (3)
The Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Higher scores indicate worse sleep quality where poor sleep will be a PSQI total score of > 5.
Measured: Change from baseline to immediately post-intervention and 3 months follow-up
Perceived Stress Scale (PSS-10)
The PSS is a 10-item scale designed to measure the perception of stress within the past month. Participants use a Likert scale with responses ranging from 0 = never to 4 = very often. PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. Additionally, scores can be categorized as low (0-13), moderate (14-26), and high (27-40) perceived stress.
Measured: Change from baseline to immediately post-intervention and 3 months follow-up
General Anxiety Disorder-7 (GAD-7)
The GAD-7 is a 7-item self-report scale based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for generalized anxiety disorder, with items scored from 0 (not at all) to 3 (nearly every day).
Measured: Change from baseline to immediately post-intervention and 3-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start15 Jan 2026 (estimated)
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Udisense DBA Nanit
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Headspace
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07302893
- Sponsor's protocol ID
- Nanit 2025-18
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population Among New Parents
- ClinicalTrials.gov ID
- NCT07302893
- Acronym / sponsor ID
- Nanit 2025-18
- Conditions
- Insomnia
- Keywords
- postpartum, CBT-I
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Udisense DBA NanitIndustry (pharma, biotech, devices)
- Collaborators
- Headspace
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital CBT-I recipients | Experimental | Behavioral: Digital CBT-Iinstructed to follow the 18-session Headspace sleep program daily |
| No intervention | No intervention | –asked to maintain their regular routines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital CBT-IHeadspace 18-session sleep program | Behavioural | Digital CBT-I recipients |
Primary outcome
Insomnia Severity Index (ISI) score
Time frame: Change from baseline to immediately post-intervention and 3 months follow-up
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.
Sleep Diary
Time frame: Change from baseline to immediately post-intervention and 3 month follow-up
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.
3 secondary outcomes
The Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline to immediately post-intervention and 3 months follow-up
Perceived Stress Scale (PSS-10)
Time frame: Change from baseline to immediately post-intervention and 3 months follow-up
General Anxiety Disorder-7 (GAD-7)
Time frame: Change from baseline to immediately post-intervention and 3-months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes. Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maristella Lucchini, Senior Clinical Researcher at Nanit, PhD contact
Natalie Barnett, VP of Clinical Research at Nanit, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital CBT-I in people with Insomnia, run by Udisense DBA Nanit at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maristella Lucchini, Senior Clinical Researcher at Nanit, PhD (1-866-696-2648, maristella.lucchini@nanit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) score (time frame: Change from baseline to immediately post-intervention and 3 months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.