Polysomnography

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

Efficacy and Safety of Seltorexant in Insomnia Disorder: A Randomized Clinical Trial

Megan George — Tue, 02 Sep 2025 13:28:04 +0000

Date Added:

September 2, 2025

Journal/Publication:

JAMA Psychiatry

Publication Date:

August 13, 2025

URL:

Efficacy and Safety of Seltorexant in Insomnia Disorder: A Randomized Clinical Trial

Type:

Clinical Research Results

Format:

Article

DOI (1):

10.1001/jamapsychiatry.2025.1999

Keywords

sleep medicine

neurology

Psychiatry and Behavioral Health

Seltorexant

Insomnia medications

sleep disorders

PMID (1):

40802194

MeSH

sleep initiation and maintenance disorders

A randomized controlled trial of a new hypnotic on sleep initiation and maintenance. James W. Mold, MD, MPH

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Importance: Existing pharmacological treatments for insomnia have significant limitations.

Objective: To assess the effective dose range, safety, and tolerability of the novel selective orexin-2 receptor antagonist seltorexant in insomnia disorder.

Design, setting, and participants: This randomized, double-blind, active- and placebo-controlled, dose-finding, polysomnography study was conducted from November 2017 to April 2019 at 55 sites in 6 countries and analyzed in August 2019. The timeline for submission of this data for publication was impacted by internal strategic decision-making. Adults (aged 18-64 years) and older adults (aged 65-85 years) with insomnia (Insomnia Severity Index score ≥15) and no psychiatric comorbidity were included.

Interventions: Participants were randomized 1:1:1:1:1 to receive nightly oral-seltorexant (5 mg, 10 mg, or 20 mg), placebo, or zolpidem (5-10 mg) for 14 days.

Main outcomes and measures: Primary and key secondary outcomes included the dose-response relationship of night 1 latency to persistent sleep (LPS) and wake after sleep onset over the first 6 hours (WASO-6). Other secondary outcomes included night 13 LPS and WASO-6. Due to asymmetrical distributions of LPS and WASO-6 at baseline, log transformation was applied and results were expressed as back-transformed least-squares mean (LSM) ratios for comparisons between groups.

Results: Overall, 364 participants (mean [SD] age, 57.8 [12.4] years; 246 [67.6%] female) received seltorexant, 5 mg (n = 71), 10 mg (n = 74), or 20 mg (n = 71); placebo (n = 75); or zolpidem (n = 73). The night 1 dose-response relationship for LPS was significant (with trend test t statistics ≥3.99 and adjusted P values <.001 for all 4 prespecified models), with greater improvements in seltorexant, 10 mg and 20 mg, vs placebo (10 mg: LSM ratio, 0.64; 90% CI, 0.51-0.81; 20 mg: LSM ratio, 0.51; 90% CI, 0.41-0.64) and in seltorexant, 20 mg, vs zolpidem (LSM ratio, 0.71; 90% CI, 0.57-0.88). The night 1 dose-response relationship for WASO-6 was also significant, with trend test t statistics ≥3.99 and adjusted P values <.001 for all 4 prespecified models (seltorexant, 10 mg: LSM ratio, 0.68; 90% CI, 0.55-0.85; seltorexant, 20 mg: LSM ratio, 0.60; 90% CI, 0.48-0.74). Night 1 LPS and WASO-6 improvements were maintained on night 13 for seltorexant, 10 mg and 20 mg, but diminished for zolpidem. On night 13, compared with zolpidem, seltorexant, 10 mg and 20 mg, improved LPS by 30% and 28%, respectively, and seltorexant, 20 mg, improved WASO-6 by 31%. Treatment-emergent adverse events (TEAEs) were lower across the combined seltorexant doses (73/216 [33.8%]) relative to placebo (37/75 [49.3%]) and zolpidem (31/73 [42.5%]). Two participants experienced serious TEAEs during the double-blind phase (1 in the seltorexant, 20 mg, group and 1 in the zolpidem group). Three participants in the seltorexant, 5 mg, and 1 in the seltorexant, 20 mg, group experienced asymptomatic electrocardiogram-related TEAEs leading to discontinuation.

Conclusions and relevance: Among participants with insomnia in this study, seltorexant, 10 mg and 20 mg, improved sleep initiation and maintenance throughout 14 days of treatment. Seltorexant was generally well tolerated.

Trial registration: ClinicalTrials.gov Identifier: NCT03375203.

Author/s:

Sofie Mesens, Andrew D Krystal, Rama Melkote, Haiyan Xu, Gahan Pandina, Jay B Saoud, Remy Luthringer, Adam Savitz, Wayne C Drevets

Diagnosis and Treatment of Obstructive Sleep Apnea

Megan George — Tue, 19 Aug 2025 16:04:58 +0000

Date Added:

August 19, 2025

Journal/Publication:

JAMA Internal Medicine

Publication Date:

August 18, 2025

URL:

Diagnosis and Treatment of Obstructive Sleep Apnea

Type:

Meta-analyses, Reviews, and Guidelines

Format:

Article

DOI (1):

40824669

Keywords

pulmonary medicine

sleep medicine

Obstructive sleep apnea

PMID (1):

10.1001/jamainternmed.2025.2318

MeSH

Sleep Apnea

Sleep Apnea, Obstructive

Polysomnography

Pulmonary

sleep apnea syndromes

A review of the diagnosis and management of patients with obstructive sleep Apnea. James W. Mold, MD, MPH

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This Clinical Insights discusses the role primary care clinicians have in screening, diagnostic testing, and treatment of patients with obstructive sleep apnea.

Author/s:

Alejandra C. Lastra, Julie M. Neborak, Babak Mokhlesi

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