# Development and Validation of a PROMIS-based Measure to Assess Postpartum Sleep

> **NIH NIH R01** · STANFORD UNIVERSITY · 2024 · $512,374

## Abstract

Impaired postpartum sleep significantly impacts postpartum recovery, maternal health, and the maternal-infant
dyad. Little is known about postpartum sleep as a construct, postpartum sleep disorders, or their association
with mental health. Data are limited to small non-racially diverse cohorts using measures with inadequate content
validity. Our pilot work demonstrates that one-third of patients with a postpartum sleep disorder have co-morbid
postnatal depression, a leading cause of maternal suicide. We propose to test our overall hypothesis that
postpartum sleep is inadequately assessed, and postpartum sleep disorders are underdiagnosed and linked to
postnatal depression. The Structured Clinical Interview for Sleep Disorders (SCISD-R) diagnoses common DSM-
5 sleep disorders, including insomnia disorder. However, SCISD-R is impractical outside research settings.
Wrist-worn actigraphy devices can also be used to measure sleep objectively. In contrast, patient-reported
outcome measures (PROs) are inexpensive, self-reported tools, which can be used to assess postpartum well-
being in large cohorts. Our recent work highlights that existing sleep PROs inadequately assess important
postpartum sleep domains such as infant sleep, nocturnal feeding patterns, awakenings, and protected maternal
sleep time. Clinicians currently lack robust PROs to assess postpartum sleep and screen for postpartum sleep
disorders. We therefore propose developing, calibrating, and validating sensitive, context-specific, sleep PROs
that capture the symptoms and dimensions of postpartum sleep, while screening for postpartum sleep disorders.
To achieve this objective, we will implement novel Patient-Reported Outcomes Measurement Information
System® (PROMIS®) ‘gap’ methodology to: (1) adapt existing PROMIS Sleep Disturbance and Sleep-Related
Impairment PROs for postpartum use by identifying new PRO items, which improve their content validity, through
qualitative interviews and focus group meetings with ≥75 stakeholders and cognitive debriefing interviews with
≥20 patients; (2) calibrate and finalize the adapted postpartum sleep PROs through psychometric evaluation in
a racially and socioeconomically diverse cohort of 640 (160 White non-Hispanic, White Hispanic, Black and
Asian) women recruited across two hospitals in Stanford, CA and Little Rock, AR. Women will complete sleep,
global health and Edinburgh Postnatal Depression Scale PROs at 4 postpartum time points (inpatient, 3 and 6
weeks, 6 months). SCISD-R will also be conducted in 300 of these women at 6 weeks and 6 months, as a gold
standard, to determine screening sensitivity and specificity of the adapted PROs. In 50 women, sleep data, (day,
nocturnal and total awake time), will also be compared between actigraphy and the adapted PROs; and (3)
characterize postpartum sleep and its association with postnatal depression using causal inference approaches.
Rigorous validation of the sleep PROs will support their widespread use t...

## Key facts

- **NIH application ID:** 10906096
- **Project number:** 5R01HL166253-02
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Pervez Sultan
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $512,374
- **Award type:** 5
- **Project period:** 2023-08-15 → 2028-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10906096

## Citation

> US National Institutes of Health, RePORTER application 10906096, Development and Validation of a PROMIS-based Measure to Assess Postpartum Sleep (5R01HL166253-02). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10906096. Licensed CC0.

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