Intranasal Treatments for Children With Sleep-Disordered Breathing: The MIST+ Randomized Clinical Trial

Importance: Symptoms of obstructive sleep apnea are common in childhood and associated with significant comorbidity. Surgical treatment with adenotonsillectomy is first-line treatment but medical treatments show potential to improve symptoms and reduce the need for surgery.

Objective: To determine the efficacy of 6 weeks of intranasal steroid (INS) compared with saline in children with obstructive sleep-disordered breathing (OSDB) with persistent symptoms after a 6-week intranasal saline run-in.

Design, setting, and participants: This was a double-blind, placebo-controlled, randomized clinical trial involving specialist clinic waitlists at 2 sites in Australia. Included were children aged 3 to 12 years. Study data were analyzed from January to June 2025.

Interventions: All children received once-daily intranasal saline for 6 weeks (run-in). Those with persisting symptoms (SDB score ≥-1) were randomized to either once-daily intranasal mometasone furoate, 50 µg, (INS) or continued saline for a further 6 weeks.

Main outcomes and measures: The primary outcome was symptom resolution (SDB score <-1). Secondary outcomes included behavior, quality of life, and parental perception of need for surgery. Analyses were adjusted for site and baseline measures.

Results: A total of 150 children (mean [SD] age, 6.2 [2.3] years; 93 male [62%]) were recruited. Of 139 children who completed the run-in phase, 41 (29.5%) had symptom resolution after saline run-in. Among 93 children randomized to intervention groups (47 INS; 46 saline), symptom resolution occurred in 35.6% (95% CI, 22.9%-50.6%) and 36.4% (95% CI, 23.5%-51.6%) of the INS and saline group, respectively, with no evidence for a clinically significant difference between groups (risk difference, -0.9%; 95% CI, -20.7% to 19.0%; P = .93). No group differences were found in secondary outcomes. Subgroup analysis did not reveal a group more or less likely to respond to medical treatment.

Conclusions and relevance: Results of this randomized clinical trial show that 6 weeks of intranasal saline resolved OSDB symptoms in nearly one-third of children. An additional 6-week course of INS or saline led to resolution in another one-third (total resolution around 50%), with no added benefit from INS. Intranasal saline is an effective short-term first-line treatment for OSDB before consideration of polysomnography or surgical intervention. Results suggest that saline should be recommended for 3 months before assessing the need for specialist referral.

Trial registration: ClinicalTrials.gov Identifier: NCT05382494.

Author/s:

Gillian M. Nixon, Deborah Anderson, Alice Baker

The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines

Brian Desmarais — Tue, 18 Feb 2020 17:15:18 +0000

Date Added:

February 18, 2020

Journal/Publication:

Annals of Internal Medicine

Publication Date:

February 18, 2020

URL:

The Management of Chronic Insomnia Disorder and Obstructive Sleep Apnea: Synopsis of the 2019 U.S. Department of Veterans Affairs and U.S. Department of Defense Clinical Practice Guidelines

Type:

Meta-analyses, Reviews, and Guidelines

DOI (1):

10.7326/M19-3575

Keywords

evaluation

sleep apnea

chronic insomnia

MeSH

sleep initiation and maintenance disorders

This is a guideline for evaluation and management of obstructive sleep apnea and chronic insomnia developed by the VA and DoD. The recommendations are concise and useful. James W. Mold, MD, MPH

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Abstract

Description:

In September 2019, the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) approved a new joint clinical practice guideline for assessing and managing patients with chronic insomnia disorder and obstructive sleep apnea (OSA). This guideline is intended to give health care teams a framework by which to screen, evaluate, treat, and manage the individual needs and preferences of VA and DoD patients with either of these conditions.

Methods:

In October 2017, the VA/DoD Evidence-Based Practice Work Group initiated a joint VA/DoD guideline development effort that included clinical stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions, systematically searched and evaluated the literature, created three 1-page algorithms, and advanced 41 recommendations using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system.

Recommendations:

This synopsis summarizes the key recommendations of the guideline in 3 areas: diagnosis and assessment of OSA and chronic insomnia disorder, treatment and management of OSA, and treatment and management of chronic insomnia disorder. Three clinical practice algorithms are also included.

The National Institutes of Health has estimated that insomnia and obstructive sleep apnea (OSA) are 2 of the most common sleep disorders in the general U.S. population and in the military and veteran populations (1). Insomnia symptoms are the most common sleep symptoms among U.S. adults, occurring in approximately 20% to 30% of adults, and the prevalence of chronic insomnia disorder ranges from 6% to 10% (2–6). The prevalence of OSA ranges from 9% to 38% and is associated with older age, higher body mass index, male sex, and menopause.

Sleep disorders are more prevalent in the populations served by the U.S. Department of Veterans Affairs (VA) and the U.S. Department of Defense (DoD) than in the general civilian population. In the RAND report “Sleep in the Military: Promoting Healthy Sleep Among U.S. Servicemembers,” 48.6% of military personnel surveyed had poor sleep quality (Pittsburgh Sleep Quality Index score >5) (7). The prevalence of insomnia symptoms has been reported to be as high as 41% in service members deployed to combat and 25% in noncombatants (8). In a large cohort of soldiers preparing for deployment, 19.9% met criteria for insomnia according to the Insomnia Severity Index (ISI) (8). A more recent study evaluated the incidence of insomnia and OSA in the entire population of U.S. Army soldiers from 1997 to 2011 (9) and showed unprecedented increases in the incidence of both conditions (652% and 600%, respectively) during this period. In military personnel referred for sleep evaluations, sleep-disordered breathing is the most frequently diagnosed disorder, and some studies have found that military personnel have high rates of comorbid insomnia and OSA (10, 11). Further, military personnel with sleep disorders often also have posttraumatic stress disorder (PTSD), symptoms of anxiety and depression, and traumatic brain injury, which can complicate diagnosis and management (11–13).

Sleep disturbances are also common in veterans (14–16). Similar to findings from active-duty service members, the National Veteran Sleep Disorder Study found that the number of veterans diagnosed with sleep disorders increased nearly 6-fold from 2000 to 2010. In this study, 4.5% of veterans were diagnosed with sleep-disordered breathing, and 2.5% were diagnosed with insomnia. However, the actual prevalence of insomnia disorder among veterans is likely to be considerably higher (17) because it is often not documented in the medical record (18, 19). Comorbid PTSD was associated with a 7.6-fold greater risk for OSA and a 6.3-fold greater risk for insomnia (15). Because veterans have high rates of cardiovascular disease and PTSD, and because OSA is more prevalent in patients with these disorders (20), there is likely a large percentage of veterans who have not yet been diagnosed with OSA (21).

Author/s:

Mysliwiec, V., Martin, J.L., Ulmer, J.S., Chowdhuri, S., Brock, M.S., Spevak, C.