sleep apnea

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.

Author/s:

Gillian M. Nixon, Deborah Anderson, Alice Baker

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

Megan George — Wed, 21 Jan 2026 18:12:26 +0000

Date Added:

January 21, 2026

Journal/Publication:

JAMA

Publication Date:

January 20, 2026

URL:

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

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamapediatrics.2025.5717

Keywords

sleep disorders

adolescents

Intranasal Treatments

sleep apnea

PMID (1):

41557344

MeSH

Humans

male

Polysomnography

sleep apnea syndromes

Once daily intranasal saline reduces sleep disordered breathing in children as well as or better than intranasal steroids. James W. Mold, MD, MPH

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Trial registration: ClinicalTrials.gov Identifier: NCT05382494.

Author/s:

Gillian M. Nixon, Deborah Anderson, Alice Baker

Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children

Rowan Hutchins — Sat, 09 Dec 2023 06:00:00 +0000

Date Added:

December 9, 2023

Journal/Publication:

JAMA

Publisher:

AMA

Publication Date:

December 5, 2023

Issue:

Volume:

330

Pages:

2084-2095

URL:

Adenotonsillectomy for Snoring and Mild Sleep Apnea in Children

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jama.2023.22114

Keywords

PMID (1):

38051326

MeSH

Sleep Apnea Syndromes* / complications

Sleep Apnea

Obstructive* / diagnosis

Snoring / complications

Polysomnography

child

Adenotonsillectomy may be helpful for some kids with snoring and mild sleep apnea. James W. Mold, MD, MPH

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Question: Among children who snore without frequent obstructive events, does early adenotonsillectomy compared with watchful waiting with supportive care improve neurodevelopment, behavior, or other symptoms at 12-month follow-up?

Findings: In this randomized clinical trial of 458 children with mild sleep-disordered breathing (SDB), adenotonsillectomy compared with watchful waiting resulted in no significant differences in executive function or attention at 12 months. The adenotonsillectomy group had improved quality of life, symptoms, behavior, and blood pressure, which were among the secondary outcomes measured.

Meaning: In children with mild SDB, adenotonsillectomy resulted in no statistically significant differences in changes in executive function or attention but led to improved secondary outcomes including symptoms, behavior, and blood pressure.

Author/s:

Susan Redline, Kaitlyn Cook, Ronald D. Chervin

Long-Term Health Outcomes in Obstructive Sleep Apnea: A Systematic Review of Comparative Studies Evaluating Positive Airway Pressure and the Validity of Breathing Measures as Surrogate Outcomes

Aubrey Delammermore — Sun, 11 Dec 2022 06:00:00 +0000

Date Added:

December 11, 2022

Journal/Publication:

Agency for Healthcare Research and Quality

Publisher:

US Department of Health and Human Services

Publication Date:

December 1, 2022

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

Keywords

CPAP

Obstructive sleep apnea

sleep apnea

systematic review

breathing measures

MeSH

Sleep Apnea, Obstructive

Patient Acuity

united states food and drug administration

continuous positive airway pressure

Sleepiness

An AHRQ-sponsored systematic review of evidence relating to the impact of CPAP on various outcomes in adults with obstructive sleep apnea. The abstract is on pages vi-vii. Spoiler alert: Very little hard evidence of benefit on key outcomes. James W. Mold MD, MPH.

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Background. Obstructive sleep apnea (OSA) is a disorder characterized by periods of airflow
cessation (apnea) or reduced airflow (hypopnea) during sleep. The diagnosis and severity of
OSA, and response to therapy, have historically been assessed using the apnea-hypopnea index
(AHI). However, several definitions of this measure exist, and the utility of the AHI and
associated measures as valid surrogate measures of health outcomes has been questioned. OSA is
commonly treated with the use of continuous positive airway pressure (CPAP) devices during
sleep. The efficacy of CPAP, including for Food and Drug Administration (FDA)
clearance/approval, has been based on changes in AHI, but the long-term effect of CPAP on
health outcomes and the role of disease severity (as measured by AHI) or sleepiness symptoms
on the putative effect of CPAP are unclear.
Methods. We searched Medline, Embase, the Cochrane databases, CINAHL, and
ClinicalTrials.gov from January 2010 through March 22, 2021; we screened reference lists of the
2011 Agency for Healthcare Research and Quality (AHRQ) OSA report and other systematic
reviews for earlier studies. We included only randomized controlled trials (RCT) and
nonrandomized comparative studies (NRCS) of CPAP that adjusted for potential confounders for
CPAP evaluation. We also included other comparative studies that reported both changes in
potential intermediate or surrogate measures (e.g., AHI) and effects on health outcomes. All
studies had to report effects on prespecified long-term (12 months for most outcomes) health
outcomes in adults with OSA. We did not evaluate sleepiness, other symptoms, or intermediate
outcomes. We excluded observational studies that did not directly compare treatment options.
Results. The 52 identified studies used highly inconsistent criteria to define breathing measures
(apneas, hypopneas, and oxygen desaturation). Definitions of respiratory disturbance events
(e.g., apneas, hypopneas) and criteria to define or categorize severity of OSA are highly
inconsistent across studies, despite frequent claims of using standard national or international
definitions. Possible differences in study findings based on heterogeneity of OSA and sleep study
measures could not be elucidated. Among 31 studies that directly compared CPAP and no CPAP
(29 studies) or sham CPAP (2 studies), 14 were RCTs (12 intention-to-treat [ITT]) and 17 were
NRCSs (11 analyses of CPAP users versus nonusers).
With one exception, RCTs did not find statistically significant effects for any cardiovascular
(CV) outcome. RCTs did not provide evidence that CPAP affects the risk of all-cause mortality
(summary effect size [ES] 0.89, 95% confidence interval [CI] 0.66 to 1.21), CV mortality
(summary ES 0.99, 95% CI 0.64 to 1.53), stroke (summary ES 0.99, 95% CI 0.73 to 1.35),
myocardial infarction (summary ES 1.05, 95% CI 0.78 to 1.41), or composite CV outcomes (ES
range 0.42 to 1.10 across studies, all statistically nonsignificant); all with low strength of
evidence (SoE). The three RCTs that aimed to be powered for composite CV events failed to
vi
show a significant or clinically meaningful effect. The NRCSs, overall, found significant
adjusted associations between CPAP use and all-cause mortality. Combining the RCTs and
NRCSs, the summary ES for all-cause mortality was ES 0.61 (95% CI 0.49 to 0.76), supporting a
low SoE of an association between CPAP use and lower risk of death. Data from the NRCSs did
not change other conclusions. Both RCTs and NRCSs provide insufficient evidence regarding
the effect of CPAP on the risk of transient ischemic attack, angina, coronary artery
revascularization, congestive heart failure, and atrial fibrillation.
RCTs also did not provide evidence that CPAP affects the risk of driving accidents or the risk of
incident diabetes (both low SoE), or that CPAP results in clinically significant changes in
depression or anxiety scores, executive cognitive function measures, or nonspecific quality of
life measures (all low SoE). RCTs provide insufficient evidence regarding the effect of CPAP on
incident hypertension, functional status measures, male or female sexual function, or days of
work missed. Data from the NRCSs did not change these conclusions.
Eligible studies provided insufficient evidence regarding possible differences in the effect of
CPAP based on patient characteristics (such as disease severity or comorbidities), different
diagnostic criteria, or whether RCTs were analyzed as ITT or “as-treated”.
Eligible studies provided insufficient evidence about adverse events due to CPAP use. Many
studies did not collect such data. Adverse events reported in the U.S. Food and Drug
Administration (FDA) database mostly related to inadequate humidification, user errors, or
device malfunction. No deaths were attributed to CPAP use.
Review of the FDA database found 163 CPAP devices used to treat adults with sleep apnea. The
large majority of FDA 510(k) Premarket Notification records cite other previously approved
CPAP devices to support claims of equivalence. The available data did not reference clinical
studies to support the device manufacturers’ claims.
Review of the National Institutes of Health’s RePORTER revealed no germane funded trials.
Review of ClinicalTrials.gov revealed a single large RCT with a mortality endpoint, but no
updating of the site since 2015 and five additional small trials (2 addressing events in patients
with paroxysmal atrial fibrillation or hypertensive pulmonary edema; 3 measuring AHI,
cognition, or kidney function).
RCTs comparing CPAP and mandibular advancement devices found no differences in depression
or anxiety symptoms (low SoE). There was insufficient evidence for other outcomes. RCTs
comparing fixed and autoCPAP found no differences in functional status; other long-term
outcomes were not reported. No eligible studies evaluated comparisons of other types of CPAP.
No studies have evaluated the validity of changes in intermediate or surrogate measures (such as
change in AHI during a clinical trial) as predictors of long-term health outcomes. No studies
reported surrogacy or mediation analyses, nor did any compare the concordance of changes in
different sleep study and symptom measures with health outcomes. Across the 15 studies that
reported both changes in intermediate or surrogate measures and effects on long-term health
vii
outcomes, data were too sparse to allow adequate cross-study evaluation of concordance between
change in any specific measure and health outcome or sleep questionnaires.
Conclusions. Studies are highly inconsistent as to how they define breathing measures during
sleep studies and OSA itself. Insufficient evidence exists to assess the validity of change in AHI
as a surrogate or intermediate measure for long-term health outcomes. Until such validation has
been conducted, it cannot be assumed that changes (e.g., improvements) in intermediate or
surrogate outcomes are correlated with long-term health outcomes.
RCTs do not provide evidence that CPAP prescription affects long-term, clinically important
outcomes. Specifically, with low SoE, RCTs do not demonstrate that CPAP affects all-cause
mortality, various CV outcomes, clinically important changes in psychosocial measures, or other
clinical events. NRCSs reported associations between CPAP use and reduced risk of all-cause
death. NRCS results did not differ from RCTs for other outcomes. We have limited confidence
that the summary estimates are close to any true effect.
Comparative studies did not adequately address whether the effect of CPAP varies based on
disease severity (e.g., as assessed by AHI), symptoms (e.g., as assessed by sleepiness scales),
other patient characteristics, different features or modes or CPAP, or different criteria or
definitions of sleep measures or OSA diagnosis.
Additional well-conducted comparative studies are needed to better assess the potential effects of
CPAP on long-term outcomes for patients with OSA, whether any particular group of patients
may benefit to a greater or lesser degree from CPAP treatment, and whether of changes in AHI
(and/or other breathing measures) are valid intermediate or surrogate measures of health
outcomes. Associations identified in comparative studies could serve as the basis for more
rigorous trials.

Author/s:

Balk, E. M., Adam, G. P., Cao, W., Bhuma, M. R., Forbes, S., Mehta, S., Panagiotou, O., D'Ambrosio, C., Trikalinos, T. A.

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.