Trial reportSleep & breathing = Schlaf & Atmung2016
An oral appliance with or without elastic bands to control mouth opening during sleep-a randomized pilot study.
Trial report in Sleep & breathing = Schlaf & Atmung, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it.
- To compare different non-surgical treatment modalities on treatment of obstructive sleep apnea: A systematic review and meta-analysis.Journal of Indian Prosthodontic SocietyPooled it
- Prediction of non-responders to oral appliance treatment of obstructive sleep apnea: a pilot study.Sleep & breathing = Schlaf & Atmung · 2025Trial
- Elastic Bands Improve Oral Appliance Treatment Effect on Obstructive Sleep Apnoea: A Randomised Crossover Trial.Journal of oral rehabilitation · 2025Trial
- Effects of mandibular advancement devices on upper airway dimensions in obstructive sleep apnea: responders versus non-responders.Clinical oral investigations · 2023Trial
- Association of Skeletal Facial Pattern With Treatment Response of Obstructive Sleep Apnoea Using Mandibular Advancement Devices - A Cluster Analysis.Journal of oral rehabilitation · 2025Article
- Obstructive sleep apnea mouth breathing phenotype response to combination oral appliance therapy.Frontiers in sleep · 2024Article
- Starting Mandibular Advancement Device Therapy in Patients with Good Protrusive Capacity: A Randomized Pilot Study.Turkish journal of orthodontics · 2023Article
- Comparative efficacy of mandibular advancement devices in obstructive sleep apnea: a network meta-analysis.Sleep & breathing = Schlaf & Atmung · 2023Article
- Oral Appliance Therapy for Obstructive Sleep Apnoea: State of the Art.Journal of clinical medicine · 2019Review
- Update on oral appliance therapy.European respiratory review : an official journal of the European Respiratory Society · 2019Review
- Changes in lower incisor irregularity during treatment with oral sleep apnea appliances.Sleep & breathing = Schlaf & Atmung · 2017Article
- Update on Oral Appliance Therapy for OSA.Current sleep medicine reports · 2017Review
- Mandibular advancement devices in obstructive sleep apnea: an updated review.Sleep science (Sao Paulo, Brazil)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOral appliances (OAs) hold the lower jaw forward to reduce obstructive sleep apneas. Some OA designs allow mouth opening, which influences the forward positioning of the lower jaw. The aim of this pilot study was to compare the efficacy of an adjustable, custom-made OA (Narval®) in its original design, which allowed mouth opening, with the same OA with elastic bands that restricted mouth opening.
methodsConsecutive patients with an apnea-hypopnea index (AHI) of ≥15 were randomized to start with an OA either with or without elastic bands in a single-blinded, crossover, pilot study. The patients underwent acclimatization and titration. After 3 weeks use of each device, they had renewed sleep apnea recordings and responded to questionnaires. Washout periods took place between the tests.
resultsTen subjects with a median AHI of 19.7 (interquartile range (IQR) 17.3 to 31.8) were included. The AHI decreased to 3.1 (IQR 1.5-14.7) (p < 0.01) with the OA and to 5.1 (IQR 2.4-14.3) (p < 0.01) with the OA with elastic bands, with no difference between them (p = 0.7). The two subjects with severe obstructive sleep apnea (OSA) almost halved their supine AHI with, as compared to without, elastic bands. The majority of the patients preferred to use the elastic bands.
conclusionsThis pilot study indicates that elastic bands markedly reduced the supine AHI in two subjects with severe sleep apnea as compared to without elastic bands. The majority of the patients preferred the use of elastic bands, although no significant difference in the AHI was observed with versus without the elastic bands in the whole sample.
Indexed as
Identifiers
26810496What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.