NCT07378839

Brief Summary

This is a prospective, two-arm, non-blinded randomized controlled study designed to evaluate the effects of a one-week alternate nostril breathing (ANB) intervention on nausea and vomiting severity in pregnant individuals during their first trimester.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress30%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

January 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

March 19, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

January 23, 2026

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Severity of Nausea and Vomiting

    Measured by the change in the Pregnancy-Unique Quantification of Emesis and Nausea (PUQE) score, where scores range from 3-15, and a higher score indicates greater severity of nausea and vomiting.

    Day 7

Study Arms (2)

Alternate Nostril Breathing

ACTIVE COMPARATOR

Participants in the intervention group will receive a brief orientation via a research team member at the time of randomization on alternate nostril breathing (ANB) and then be provided with a written and video-based instructional guide. They will be instructed to perform ANB 3 times per day for 5-10 minutes per session over a 7-day period and document their sessions in a daily symptom diary. The 7-day period will begin the following day after enrollment to allow for a full day of intervention implementation (Day 1-7).

Behavioral: Alternate Nostril Breathing

Usual Care Only

NO INTERVENTION

This group will receive usual care and complete a daily symptom diary for Day 1-7.

Interventions

ANB 3 times per day for 5-10 minutes per session over a 7-day period

Alternate Nostril Breathing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant individuals aged 18 years or older
  • Viable pregnancy with a gestational age between 6 0/7 - 12 6/7 weeks of gestation, confirmed by last menstrual period or ultrasound
  • Diagnosed with mild to moderate NVP (PUQE-24 score between 4-12)
  • Ability to understand and read English

You may not qualify if:

  • Severe nausea and vomiting, defined as a PUQE score \>12, or diagnosis of hyperemesis gravidarum requiring hospitalization or intravenous fluid therapy
  • Pre-existing, active or acute respiratory conditions (e.g., asthma, COPD)
  • History of severe anxiety disorders affecting breathing patterns
  • Known deviated nasal septum
  • Nausea and vomiting that pre-dates the pregnancy or is suspected to be due to a etiology other than pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Shilpa Babbar

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

January 30, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

March 19, 2026

Record last verified: 2026-03

Locations